MA- Monitoring-Under Approval

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No. Reference No. Brand Name Generic Name GMP Status Assessment Pathway Application Date Date 1st Assessment Date 2nd Assessment Time monitor
10576/2019LYSODOL 200SRACECLOFENAC NOT APPLIED ABRIDGED 2019-02-20
Application Date
2023-11-142023-11-291,917 days
20578/2019LYSODOL MRACECLOFENAC & PARACETAMOL & CHLORZOXAZONE NOT APPLIED ABRIDGED 2019-02-20
Application Date
2023-11-202023-11-301,917 days
30577/2019LYSODOL PACECLOFENAC & PARACETAMOL NOT APPLIED ABRIDGED 2019-02-20
Application Date
2023-11-152023-12-011,917 days
40738/2019EFFERALGAN-600PARACETAMOL APPLIED FOR GMP ABRIDGED 0000-00-00
Round-2
2023-07-030000-00-00739,424 days
50733/2019EFFERALGAN-80PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Round-1
2020-10-092021-01-26739,424 days
63960/2019APHAMALGAN FOR PERFUSIONPARACETAMOL APPLIED FOR GMP RECOGNITION 2019-03-12
Application Date
2023-08-08Undefined
7867/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG/1000MG NOT APPLIED RECOGNITION 2019-03-15
Application Date
2022-11-092024-04-231,894 days
8871/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MG NOT APPLIED RECOGNITION 2019-03-15
Application Date
2021-02-222021-04-221,894 days
9870/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 25MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 25MG/1000MG NOT APPLIED RECOGNITION 2019-03-15
Application Date
2022-11-102024-04-221,894 days
101027/2019ETROBAX 90ETORICOXID NOT APPLIED ABRIDGED 2019-04-01
Application Date
2023-11-222023-12-271,877 days
113110/2018ACUDOL 15 INJKETOTOLAC TROMETHAMANE NOT APPLIED RECOGNITION 2019-04-01
Application Date
2022-11-012023-11-041,877 days
123109/2018ACUDOL 30 INJKETOTOLAC TROMETHAMANE NOT APPLIED RECOGNITION 2019-04-01
Application Date
2022-11-012022-11-031,877 days
131020/2019OXYTOCIN 5IUOXYTOCIN NOT APPLIED RECOGNITION 2019-04-01
Application Date
2023-11-192024-03-281,877 days
141021/2019OXYTOCIN 10IUOXYTOCIN NOT APPLIED RECOGNITION 2019-04-01
Application Date
2023-08-062024-01-091,877 days
151024/2019CANDIVOR INJVORICONAZOLE NOT APPLIED RECOGNITION 2019-04-01
Application Date
2021-06-142021-06-231,877 days
161109/2019MICROGYNON EDLEVONORGESTREL/ETHINYLESTRADIOL APPLIED FOR GMP RECOGNITION 2019-04-08
Application Date
2023-06-202023-06-261,870 days
171191/2019FLEXDOL ® TABLETSIBUPROFEN, METHOCARBAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-15
Application Date
2020-11-182020-12-101,863 days
181269/2019 PIRONEM INJECTIONMEROPENEM NOT APPLIED ABRIDGED 2019-04-23
Application Date
2021-06-142021-06-221,855 days
191288/2019C-TAX P DRY SYRUP CEFIXIME APPLIED FOR GMP RECOGNITION 2019-04-25
Application Date
2022-11-102023-01-111,853 days
201418/2019AMLOZAAR-H AMLODIPINE 5MG/LOSARTAN POTASSIUM 50MG/HYDROCHLOROTHIAZIDE 12.5MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-05-07
Application Date
2023-11-082024-04-221,841 days
211493/2019MEFTAL-500 MEFENAMIC ACID BP APPLIED FOR GMP RECOGNITION 2019-05-14
Application Date
2021-01-292021-02-151,834 days
221530/2019GYNASTATIN NYSTATIN BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Round-1
2021-11-022021-10-05739,424 days
231548/2019PARACETAMOL FRESENIUS PARACETAMOL FRESENIUS APPLIED FOR GMP RECOGNITION 2019-05-20
Application Date
Undefined
241802/2019ACEM-500CLARITHROMYCIN APPLIED FOR GMP ABRIDGED 2019-05-30
Application Date
Undefined
251992/2019DESLORASTAL DESLORATADINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05
Application Date
Undefined
261996/2019DIPARA DICLOFENAC + PARACEUTAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05
Application Date
Undefined
271401/2019ACTILOR SYRUPDESLORATADINE SYRUP NOT APPLIED RECOGNITION 2019-06-05
Application Date
2023-11-092024-02-261,812 days
281997/2019ESOPRAZOLE - 40MG ESOMEPRAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05
Application Date
Undefined
291994/2019AZAL- 500MGAZITHROMYCINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05
Application Date
2023-08-24Undefined
302000/2019ARTESUNATE & AMODIAQUINE TAB ARTESUNATE & AMODIAQUINE GMP CERTIFICATE AVAILABLE ABRIGDED 2019-06-05
Application Date
2021-08-19Undefined
311999/2019ARTESUNATE & AMODIAQUINE TAB ARTESUNATE & AMODIAQUINE TAB (25/67.5MG) GMP CERTIFICATE AVAILABLE RECOGNITION 2019-06-05
Application Date
2021-08-192021-08-211,812 days
322411/2019BUDECOT 0.5MG BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-03
Application Date
2021-06-282021-07-171,784 days
332412/2019ERLOCIP 25 ERLOTINIB TABLETS 25MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-03
Application Date
Undefined
342565/2019ARTIM ARTEMETHER INJECTION 80MG/ML() 1ML INJECTION GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-16
Application Date
2019-08-062021-08-081,771 days
3517802/2017TORSINEX-20 TABLETSTORSEMIDE 20 MG TABLETS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-24
Application Date
2022-04-22Undefined
362813/2019& 2814/2019PERFALGAN 10MG/ML SOLUTION FOR PERFUSION 100ML& 50MLPARACETAMOL APPLIED FOR GMP ABRIDGED 2019-08-01
Application Date
Undefined
372877/2019POSITON CREAMTRIMCINOLONE ACETONIDE, NEOMYCIN SULPHATE, NYSTATIN NOT APPLIED ABRIDGED 2019-08-07
Application Date
2021-02-162021-06-211,749 days
382443/2019ATAZOR-R-300/100ATANAVIR SULPHATE/RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-07
Application Date
2023-12-20Undefined
392905/2019LABGENTIL TABLETSSECNIDAZOLE 500MG TABLETS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-08-13
Application Date
2023-12-072023-11-121,743 days
402984/2019NEWCOX - TH ETORICOXIB&THIOCOLCHICOSIDE NOT APPLIED ABRIDGED 2019-08-20
Application Date
2024-01-222024-02-021,736 days
412976/2019PHARMADOL - 10 PARACETAMOL CAPLETS 500MG NOT APPLIED ABRIDGED 2019-08-20
Application Date
2023-11-142023-12-051,736 days
423358/2018WOSULIN N-100ISOPHANE INSULINE N APPLIED FOR GMP ABRIDGED 2019-08-21
Application Date
2022-11-092023-02-071,735 days
433065/2019MONTIKAST 10 MONTELUKAST 10MG NOT APPLIED ABRIDGED 2019-08-23
Application Date
2024-03-282024-04-231,733 days
443148/2019DREZ-V GELMICONAZOLE NITRATE&METRONIDAZOLE GEL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-27
Application Date
2020-03-072020-06-221,729 days
453190/2019EFAVIRENZ 400MG/LAMIVUDINE 300MG/TENOFOVIR 300MG)EFAVIRENZ 400MG/LAMIVUDINE 300MG/TENOFOVIR 300MG) GMP CERTIFICATE AVAILABLE ABRIDGED 2019-08-30
Application Date
2023-11-222024-04-121,726 days
463273/2019FRESENIUS PROPOVEN 1%PROPOFOL APPLIED FOR GMP ABRIDGED 2019-09-06
Application Date
2023-11-212023-12-081,719 days
473333/2019ZENSALBU NEBULE 2.5 SALBUTAMOL 2.5MG/2.5ML NOT APPLIED ABRIDGED 2019-09-11
Application Date
2023-11-152023-12-011,714 days
483350/2019EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-09-12
Application Date
2024-04-24Undefined
493459/2019XAROBANRIVAROXABAN APPLIED FOR GMP ABRIDGED 2019-09-20
Application Date
2023-11-212023-11-301,705 days
503476/2019PYLOOCAIN OINTMENT (ANTI HAEMORRHOIDAL OINTMENT), 30G ANTI HEMORRHOIDAL OINTMENT NOT APPLIED ABRIDGED 2019-09-23
Application Date
2023-11-222023-12-271,702 days
513490/2019KODOXY DOXYCYCLINE BP APPLIED FOR GMP ABRIDGED 2019-09-23
Application Date
2021-07-012021-07-071,702 days
523560/2019LARINATEArtesunate GMP CERTIFICATE AVAILABLE RECOGNITION 2019-09-27
Application Date
Undefined
533560/2019LUMERAX-DTARTEMETHER & LUMEFANTRINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-09-28
Application Date
Undefined
543773/2019SALBUCORT INHALERSALBUTAMOL NOT APPLIED ABRIDGED 2019-10-14
Application Date
2023-11-142023-12-041,681 days
553834/2019ABACAVIR,DOLUTEGRAVIR,LAMUVIDINEABACAVIR,DOLUTEGRAVIR,LAMUVIDINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-10-18
Application Date
2024-02-202024-02-231,677 days
563863/2019PRELYNCA-50PREGABALIN NOT APPLIED RECOGNITION 2019-10-21
Application Date
2024-03-20Undefined
573862/2019PRELYNCA-75PREGABALIN NOT APPLIED RECOGNITION 2019-10-21
Application Date
2024-03-202024-03-211,674 days
583868/2019GLIPMEVIA 50/1000 SITAGLIPTIN + METFORMIN HCL APPLIED FOR GMP ABRIDGED 2019-10-21
Application Date
2021-08-162021-08-211,674 days
593871/2019GLIPMEVIA 50/500 SITAGLIPTIN + METFORMIN HCL APPLIED FOR GMP ABRIDGED 2019-10-21
Application Date
Undefined
603869/2019GLIPMEVIA 50/850SITAGLIPTIN + METFORMIN HCL NOT APPLIED ABRIDGED 2019-10-21
Application Date
2023-11-232023-12-271,674 days
613885/2019CO-MICARDIS 40/12.5TELMISARTANT 40MG+HYDROCHLOROTHIAZIDE 12.5MG NOT APPLIED ABRIDGED 2019-10-21
Application Date
2021-07-092021-08-041,674 days
623884/2019CO-MICARDIS 80/12.5TELMISARTANT 80MG+HYDROCHLOROTHIAZIDE 12.5MG NOT APPLIED ABRIDGED 2019-10-21
Application Date
2023-09-052023-12-271,674 days
633888/2019MICROLUT LEVONORGESTREL APPLIED FOR GMP RECOGNITION 2019-10-21
Application Date
2024-04-22Undefined
643909/2019MICROMOX EYE DROPMOXIFLOXACIN AS HYDROCHLORIDE APPLIED FOR GMP ABRIDGED 2019-10-22
Application Date
Undefined
653923/2019 ADOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-10-22
Application Date
2021-11-152023-03-251,673 days
663938/2019EFFERALGAN 1000MG, FRUITS ROUGES, EFFERVESCENT TABLETS, BOX OF 8 TABLETSPARACETAMOL APPLIED FOR GMP ABRIDGED 2019-10-23
Application Date
2021-08-202021-08-261,672 days
674022/2019MICARDIS-40TERMISARTAN NOT APPLIED ABRIDGED 2019-10-29
Application Date
2024-04-292024-04-301,666 days
684021/2019MICARDIS-80TERMISARTAN NOT APPLIED ABRIDGED 2019-10-29
Application Date
2021-07-062021-08-051,666 days
694071/2019PIRITON CHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-01
Application Date
2023-09-082023-11-081,663 days
704072/2019CALPOL SUSPENSIONPARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-01
Application Date
2021-07-142021-08-081,663 days
714070/2019PANADOL ADVANCE PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-01
Application Date
2023-08-092023-08-141,663 days
724124/2019EROCIN-250EURTHROMYCIN STREATE BP GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-06
Application Date
2023-08-07Undefined
734396/2019KOFLYN PINEAPPLE FLAVOUR COUGH EXPECTORANT CHLORAMPHENIRAMINE MALEATE, AMMONIUM CHLORIDE, SODIUM CITRATE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-19
Application Date
2020-07-14Undefined
744416/2019GACET -250ACETAMINOPHEN UPS APPLIED FOR GMP RECOGNITION 2019-11-20
Application Date
2020-10-272020-11-171,644 days
754418/2019GACET -125 ACETAMINOPHEN UPS APPLIED FOR GMP RECOGNITION 2019-11-20
Application Date
2020-10-222020-11-191,644 days
764428/2019FUNBACT-A CREAM CLOTRIMAZOLE, BETAMETHASONE, DIPROPIONATE NOT APPLIED RECOGNITION 2019-11-20
Application Date
2023-08-242023-12-041,644 days
774423/2019ANOMEX HYDROCOTISONE ACATATE, LIDOCAINE , ZINC OXIDE & ALLANTOIN SUPPOSITORY GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-20
Application Date
2023-06-112024-04-221,644 days
784427/2019KLOVINAL METRONIDAZOLE, CLOTRIMAZOLE, LACTO BACILLUS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-20
Application Date
2024-03-272024-04-221,644 days
793360/2019DIGOXINDIGITALIS APPLIED FOR GMP ABRIDGED 2019-11-21
Application Date
2023-11-242023-12-281,643 days
804100/2019INTELENCE-100INTRAVIRINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-22
Application Date
Undefined
814761/2019COTRIZIM 480 MGSULFAMETHOXAZOLE 400MG/TRIMETHOPRIM 80MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03
Application Date
2023-11-062024-04-221,631 days
824764/2019COLCIBID-200CELECOXIB GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03
Application Date
Undefined
834766/2019CEFAZIM-200MGCEFIXIME GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03
Application Date
2024-04-292024-05-021,631 days
844755/2019ESOZIM-40ESOMEPRAZOLE MAGNESIUM DR CAPSULES USP 40MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03
Application Date
2023-11-272024-01-031,631 days
854851/2019D5 GLUCOSE APPLIED FOR GMP ABRIDGED 2019-12-05
Application Date
2021-07-312021-09-071,629 days
864854/2019CIPROFLOXACIN 0.2%CIPROFLOXACIN APPLIED FOR GMP ABRIDGED 2019-12-05
Application Date
2021-11-082021-12-081,629 days
874861/2019NIRMET METRONIDAZOLE APPLIED FOR GMP RECOGNITION 2019-12-05
Application Date
2021-07-072021-07-191,629 days
884984/2019STOPKOF- PDIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE APPLIED FOR GMP ABRIDGED 2019-12-11
Application Date
2023-11-302024-04-221,623 days
894991/2019NIPINE-10NIFEDIPINE NOT APPLIED ABRIDGED 2019-12-11
Application Date
2023-11-292024-04-221,623 days
904993/2019NIPINE-20NIFEDIPINE NOT APPLIED ABRIDGED 2019-12-11
Application Date
2021-04-062021-04-121,623 days
915369/2019DAWACLOX-250 PACK 10x10CLOXACILLINE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27
Application Date
2023-09-062024-04-221,607 days
925373/2019MOXACIL DS-250 (100ML& 60ML)AMOXYCILLINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27
Application Date
2021-04-062021-04-291,607 days
935381/2019MOXACIL-125 (100ML&60ML)AMOXYCILLINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27
Application Date
2023-09-142024-01-151,607 days
945377/2019ERYTHROX-250 (10X10 & 1000)ERYTHROMYCINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27
Application Date
2024-03-192024-03-211,607 days
951390/2020TRISPORIN SPCEFDINIR NOT APPLIED ABRIDGED 2020-02-12
Application Date
2020-07-262021-07-271,560 days
961881/2020PANADOL EXTRA WITH OPTIZORBPARACETAMOL+CAFFEINE NOT APPLIED ABRIDGED 2020-02-24
Application Date
2023-12-142023-12-151,548 days
973412/2019 & 1997/2020ORCHAZID KETOTIFEN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-02-26
Application Date
2023-08-142024-04-221,546 days
984849/2020& 7583/2020AMARYL-M 2/500 IRGLIMEPIRIDE +METFORMIN NOT APPLIED ABRIDGED 2020-03-11
Application Date
2024-04-112024-04-151,532 days
99CANDID-2020CANDID DUSTING POWDERCLOTRIMAZOLE USP NOT APPLIED ABRIDGED 2022-03-04
Round-1
2022-03-242022-08-08809 days
1003475/2018OPELAN ODT OLANZAPINE ORODISPERSIBLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-05-04
Application Date
2021-06-24Undefined
101BENYLINORIG-2020BENYLIN ORIGINALDIPHENHYDRAMINE HYDROCHLORIDE/ AMMONIUM CHLORIDE APPLIED FOR GMP ABRIDGED 2020-05-04
Application Date
2021-04-212021-04-291,478 days
102BENYLINCOD-2020BENYLIN WITH CODEINEDIPHENHYDRAMINE HYDROCHLORIDE/ AMMONIUM CHLORIDE/ CODEINE PHOSPHATE APPLIED FOR GMP ABRIDGED 2020-05-04
Application Date
2024-04-22Undefined
103EROSTINSUSP-2020EROSTIN SUSPENSIONEBASTINE GMP CERTIFICATE AVAILABLE RECOGNITION 2020-05-28
Application Date
2023-09-162023-11-161,454 days
104EROSTIN-2020EROSTIN TABLETSEBASTINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-05-28
Application Date
2023-09-122023-11-161,454 days
1054616/2020MOXVID-500AMOXICILLIN APPLIED FOR GMP ABRIDGED 2020-06-24
Application Date
2024-03-22Undefined
1064630/2020NOVAMENTIN-625AMOXICILLIN& CLAVULANATE POT APPLIED FOR GMP ABRIDGED 2020-06-24
Application Date
2022-11-022022-11-101,427 days
1074622/2020CLOXVID-250CLOXACILLIN APPLIED FOR GMP ABRIDGED 2020-06-24
Application Date
2021-08-132021-08-141,427 days
1084841/2020NOZINAN-25LEVOMEPRAZINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-06-30
Application Date
2021-08-052021-11-121,421 days
1094840/2020NOZINAN-100LEVOMEPRAZINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-06-30
Application Date
2021-11-152021-11-241,421 days
1104887/2020LIMZEROMEPRAZOLE & DOMPERIDONE APPLIED FOR GMP RECOGNITION 2020-07-02
Application Date
2023-03-142023-08-101,419 days
1114907/2020MYOXERILCYCLOBENZAPRINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-02
Application Date
2024-03-192024-03-211,419 days
1124985/2020EROCIN-500ERYTHROMYCINE NOT APPLIED ABRIDGED 2020-07-08
Application Date
2021-08-182021-08-191,413 days
1134993/2020DOXIL-100DOXYCYCLINE HYCATE USP NOT APPLIED ABRIDGED 2020-07-08
Application Date
2021-08-132021-08-141,413 days
1144984/2020EROCIN-250ERYTHROMYCINE NOT APPLIED ABRIDGED 2020-07-08
Application Date
2021-08-172021-08-171,413 days
1154986/2020AZITAR-500AZITHROMYCIN NOT APPLIED ABRIDGED 2020-07-08
Application Date
2020-07-032021-08-031,413 days
1164994/2020MAXI-500 NOT APPLIED ABRIDGED 2020-07-08
Application Date
2020-07-082021-07-231,413 days
1175208/2020DOLIMEX-1000PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13
Application Date
2021-08-162021-08-171,408 days
1185203/2020DOLIMEX-200PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13
Application Date
Undefined
1195206/2020DOLIMEX-500PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13
Application Date
2021-08-172021-08-181,408 days
1205204/2020DOLIMEX-300PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13
Application Date
2021-08-162021-08-171,408 days
1215452/2020TROGYL SUSPENSIONMETRONIDAZOLE BENZOATE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-07-21
Application Date
2021-08-192021-08-201,400 days
1225508/2020ACINET 625AMOXICILLIN + CLAVULATE POTASSIUM NOT APPLIED ABRIDGED 2020-07-23
Application Date
2023-08-232023-11-271,398 days
1235570/2020COFANTRINE ADULTESARTEMETHER& LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27
Application Date
2021-08-182021-08-191,394 days
1245565/2020COFANTRINE DISPERSIBLEARTEMETHER+ LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27
Application Date
2021-08-202021-08-211,394 days
1255541/2020MEROSAN INJECTIONMEROPENEM TRIHYDRATE & SODIUM CARBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27
Application Date
2021-08-112021-08-121,394 days
1265563/2020DIAFORMINE 850METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27
Application Date
2021-08-152021-08-181,363 days
1275566/2020DIAFORMINE 500METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27
Application Date
2021-08-182021-08-191,363 days
1285557/2020DIAFORMINE 1000METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27
Application Date
2021-08-172021-08-181,363 days
1295552/2020RINOGRIPPARACETAMOL+ PHENIRAMINE MALEATE+ ASCORBIC ACID GRANULES GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27
Application Date
2021-08-162021-08-191,363 days
1305562/2020GYNOSPANPHLOROGLUCINOL& TRIMETYLPHOROGLUCINOL APPLIED FOR GMP FULL ASSESSMENT 2020-08-27
Application Date
2021-08-172021-08-191,363 days
1315568/2020GYNOSPAN SUPPOPHLOROGLUCINOL& TRIMETYLPHOROGLUCINOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27
Application Date
2021-08-202021-08-211,363 days
1323913/2019& 6657/2020GRAMOCEF-O-100 DRY SYRUP, 100 MLCEFIXIME USP 100MG/5ML APPLIED FOR GMP ABRIDGED 2020-09-21
Application Date
Undefined
1336707/2020SANDIMMUM NEORAL-25CICLOSPORIN NOT APPLIED ABRIDGED 2020-09-22
Application Date
2024-03-202024-03-201,337 days
1346698/2020SANDIMMUM NEORAL-100CICLOSPORIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-09-22
Application Date
2021-08-172021-08-201,337 days
1357148/2020MENOTAS HP 150MENOTROPHIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-10-14
Application Date
2023-12-272023-12-281,315 days
1367294/2020DEXO INJECTION GMP CERTIFICATE AVAILABLE ABRIDGED 2020-10-21
Application Date
2021-04-082021-05-081,308 days
1377951/2020Jadelle 2 x 75 mg implantsLevonorgestrel NOT APPLIED RECOGNITION 2020-11-20
Application Date
2024-03-112024-03-151,278 days
1387952/2020Mirena Levonorgestrel NOT APPLIED RECOGNITION 2020-11-20
Application Date
2024-02-052024-02-091,278 days
1397949/2020ASPIRIN CARDIOACETYLSALICYLIC ACID GMP CERTIFICATE AVAILABLE RECOGNITION 2020-11-20
Application Date
2024-04-292024-05-021,278 days
1407959/2020MICROGYNON ED FEETHINYLESTRADIOL/ LEVONOGESTREL APPLIED FOR GMP ABRIDGED 2020-11-20
Application Date
2024-04-032024-04-151,278 days
1417954/2020NORIGYNONNORETHISTERONE ENANTATE AND ESTRADIOL VALERATE APPLIED FOR GMP ABRIDGED 2020-11-20
Application Date
2024-04-02Undefined
1428037/2020CIPYNE CAPSULESPARACETAMOL/ IBUPROFEN/ CODEINE PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-11-25
Application Date
Undefined
1438538/2020FLAGENTYLSECNIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-17
Application Date
2021-07-192021-07-271,251 days
1448582/2020NERVILIN NTPREGABALIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
2023-11-20Undefined
1458624/2020LORI-DIAZEPAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21
Application Date
2024-03-252024-04-151,247 days
1468610/2020AMOXIMED 250AMOXICILLIN NOT APPLIED RECOGNITION 2020-12-21
Application Date
2021-08-182021-08-191,247 days
1478618/2020AMOXIMED 500AMOXICILLIN NOT APPLIED RECOGNITION 2020-12-21
Application Date
2021-08-022021-08-271,247 days
1488613/2020ELMOX 250AMOXICILLIN APPLIED FOR GMP ABRIDGED 2020-12-21
Application Date
2023-09-122023-09-251,247 days
1498578/2020IBUPAR SUSPENSION GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
Undefined
1508580/2020TRIMOXOL SUSPENSIONSULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
Undefined
1518599/2020JUNIOR ZINC TABLETSZINC SULPHATE MONOHYDRATE USP GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
Undefined
1528621/2020WOMNIL SUSPENSIONALBENDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
Undefined
1538594/2020MOXAFORTE SUSPENSIONFLUCLOXACILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21
Application Date
Undefined
1548710/2020LOTENZ AHLOSARTAN POTASSIUM/AMLODIPINE/ HYDROCHLORTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-23
Application Date
Undefined
1558761/2020MUCOLYN SYRUPAMMONIUM CHLORIDE/ BROMHEXINE HYDROCHLORIDE/ CHLORPHENIRAMINE MALEATE/ DEXTROMETHORPHAN HYDROBROMIDE NOT APPLIED RECOGNITION 2020-12-24
Application Date
2022-11-08Undefined
1568750/2020BETADINE STANDARDISED MICROBICIDAL SOLUTION 5%POVIDONE- IODINE USP APPLIED FOR GMP RECOGNITION 2020-12-24
Application Date
2021-08-052021-08-061,244 days
1578749/2020BETADINE ANTISEPTIC CREAM 5%POVIDONE- IODINE USP APPLIED FOR GMP RECOGNITION 2020-12-24
Application Date
2021-08-052021-08-061,244 days
1588762/2020PED ZINC TABLETZINC SULPHATE MONOHYDRATE USP APPLIED FOR GMP ABRIDGED 2020-12-24
Application Date
2021-08-142021-08-251,244 days
1598833/2020SERETIDE 50/250MCG DISKUSSALMETEROL XINAFOATE MICRONIZED /FLUTICASONE PROPRIONATE MICRONIZED GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30
Application Date
Undefined
1608835/2020SERETIDE 50/100MCG DISKUSSALMETEROL XINAFOATE MICRONIZED/FLUTICASONE PROPRIONATE MICRONIZED GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30
Application Date
2023-06-202023-06-221,238 days
1618836/2020SERETIDE 50/500MCGSALMETEROL XINAFOATE/FLUTICASONE PROPRIONATE GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30
Application Date
2023-06-212023-06-231,238 days
1628842/2020AUGMENTIN 500/62.5MGAMOXICILLIN /CLAVULANIC ACID APPLIED FOR GMP ABRIDGED 2022-03-07
Round-1
2022-08-102022-08-22806 days
1638877/2020BONCARE PLUSMETHYLSULFONYLMETHANE/ GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE/ CHONDROITIN SULPHATE SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-30
Application Date
2021-08-162021-08-171,238 days
1640341/2021ACTIMAGMAGNESIUM PIDOLATE NOT APPLIED ABRIDGED 2021-01-18
Application Date
2023-12-122023-12-191,219 days
1650343/2021TRAUSAN 50ML CITICHOLONE NOT APPLIED ABRIDGED 2021-01-18
Application Date
2023-09-142023-12-141,219 days
1660594/2021LUTENYL 5MGNOMEGESTROL ACETATE NOT APPLIED RECOGNITION 2021-01-29
Application Date
2023-09-062024-02-271,208 days
1670593/2021ANTADYSFLURBIPROFEN NOT APPLIED ABRIDGED 2021-01-29
Application Date
2023-03-072023-03-071,208 days
1680906/2021VANTOX CP 1GVANCOMYCIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-11
Application Date
2023-12-132024-04-161,195 days
1690937/2021LORHISTINA SYRUPLORATADINE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-12
Application Date
2023-03-152023-03-161,194 days
1700938/2021PRAZITEL 600MGPRAZIQUANTEL GMP CERTIFICATE AVAILABLE RECOGNITION 2021-02-12
Application Date
2024-04-23Undefined
1710933/2021MELANEZ 1GMESALAZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-02-12
Application Date
2021-01-312024-03-181,194 days
1721063/2021ZEE-1LEVONORGESTREL APPLIED FOR GMP ABRIDGED 2021-02-18
Application Date
2022-02-012022-02-101,188 days
1731060/2021ATOSAR-HLOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE APPLIED FOR GMP FULL ASSESSMENT 2022-03-02
Round-1
2023-03-142023-03-17811 days
1741346/2021ACUPANNEFOPAM NOT APPLIED RECOGNITION 2021-03-03
Application Date
2024-01-032024-01-041,175 days
1751386/2021LUMITER 80/480ARTEMETHER+ LUMEFANTRINE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-03-04
Application Date
2024-01-29Undefined
1761535/2021PIRICAM-20PIROXICAM APPLIED FOR GMP RECOGNITION 2021-03-10
Application Date
Undefined
1771619/2021CALOSHELL-500CALCIUM+COLECALCIFEROL APPLIED FOR GMP ABRIDGED 2021-03-15
Application Date
2023-08-232023-09-131,163 days
1782112/2021OFZOLE 30 TABSOFLOXACIN + ORNIDAZOLE APPLIED FOR GMP ABRIDGED 2021-03-31
Application Date
2023-11-042023-11-141,147 days
1792113/2021NAC MR 10 TABSDICLOFENAC POTASSIUM/PARACETAMOL/ CHLORZOXANE APPLIED FOR GMP ABRIDGED 2021-03-31
Application Date
Undefined
1802340/2021ALCOF-C SIROPDEXTROMETHORPHAN/ CETREZINE/ PHENYLEPHERINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-09
Application Date
2021-07-252024-03-121,138 days
1812738/2021SINAREST PAEDIATRIC NASAL DROPSOXYMETHAZOLINE HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-20
Application Date
Undefined
1822731/2021LOSATRUST HLOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-20
Application Date
2021-11-212024-02-281,127 days
183DYNAMOGEN-2021DYNAMOGEN ARGININE ASPARTATE NOT APPLIED RECOGNITION 2021-04-27
Application Date
2023-11-272023-12-041,120 days
1843446/2021DISLEP 25MGLEVOSULPIRIDE NOT APPLIED RECOGNITION 2021-05-14
Application Date
2023-06-202023-08-071,103 days
1853645/2021ABACAVIR AND LAMIVUDINE TABLETS USP 600/300MGABACAVIR AND LAMIVUDINE TABLETS USP 600/300MG GMP CERTIFICATE AVAILABLE ABRIDGED 2021-05-20
Application Date
Undefined
1863649/2021TENOFOVIR/LAMIVUDINETENOFOVIR/LAMIVUDINE APPLIED FOR GMP ABRIDGED 2021-05-20
Application Date
2024-04-22Undefined
1873647/2021LAMIVUDINE/ZIDOVUDINE LAMIVUDINE/ZIDOVUDINE APPLIED FOR GMP ABRIDGED 2021-05-20
Application Date
2024-04-192024-04-281,097 days
1883663/2021EMTRICITABINE/ TENOFOVIR DFEMTRICITABINE/ TENOFOVIR DF APPLIED FOR GMP ABRIDGED 2021-05-20
Application Date
2024-04-232024-04-281,097 days
1893720/2021CLAMOXYL 500MGAMOXICILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-05-24
Application Date
2023-11-152024-03-201,093 days
1903883/2021TRD-CONTIN 100TRAMADOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-05-31
Application Date
2022-02-072024-03-121,086 days
1914016/2021AGOLACTONE-25 SPIRONOLACTONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03
Application Date
2024-03-272024-04-041,083 days
1924015/2021AGODIC GELDICLOFENAC GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03
Application Date
2023-03-252024-03-121,083 days
1934004/2021AGO-C 500 TABLETASCORBIC ACID GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-03
Application Date
2024-04-222024-04-231,083 days
1944013/2021AGOMIDE TABLETFUROSEMIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-03
Application Date
2023-08-102024-04-241,083 days
1954285/2021SKDERM CREAMBETAMETHASONE DIPROPRIONATE/ CLOTRIMAZOLE & GENTAMICIN SULFATE GMP CERTIFICATE AVAILABLE RECOGNITION 2021-06-14
Application Date
2024-04-222024-05-021,072 days
1964336/2021VOLTFASTDICLOFENAC POTASSIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-16
Application Date
2022-04-202022-04-251,070 days
1975055/2021LOTEM SUSPENSIONIBUPROFEN/ PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-07-14
Application Date
2023-11-072023-11-221,042 days
1985701/2021SENIDOLSECNIDAZOLE APPLIED FOR GMP ABRIDGED 2023-07-17
Round-1
2023-08-172023-08-22309 days
1995870/2021PANFOR PR-500MG METFORMIN HYDROCHLORIDE APPLIED FOR GMP RECOGNITION 2021-08-19
Application Date
2022-11-08Undefined
2005900/2021AGO-CPMCHLORPHENIRAMINE MALEATE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19
Application Date
2024-03-122024-03-131,006 days
2015912/2021AGODINE -TSPOVIDONE IODINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19
Application Date
2024-03-212024-03-031,006 days
2025898/2021AGOMOL-100 TABLETSPARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19
Application Date
2024-03-182024-03-281,006 days
2035873/2021FLOEZYTAMSULOSIN HYDROCHLORIDE NOT APPLIED RECOGNITION 2021-08-19
Application Date
2024-04-18Undefined
2046042/2021SPAMOX 500 CAPSULESAMOXICILLIN APPLIED FOR GMP RECOGNITION 2021-08-24
Application Date
2023-12-012023-12-051,001 days
2056558/2021AMVA DENK 10/160MGAMLODIPINE/ VALSARTAN NOT APPLIED RECOGNITION 2021-09-03
Application Date
2023-09-292023-10-03991 days
2067270/2021AMVA DENK 5/160MGAMLODIPINE/ VALSARTAN NOT APPLIED RECOGNITION 2021-09-20
Application Date
2023-08-082024-03-25974 days
2077328/2021AGONOR NORFLOXACIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-21
Application Date
2024-03-192024-03-24973 days
2087324/2021CETAPIRPIRACETAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21
Application Date
2024-03-272024-04-01973 days
2097322/2021AGOVIR-TABLETACICLOVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21
Application Date
2024-03-152024-03-15973 days
2107547/2021ZYLORIC-200ALLOPURINOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-24
Application Date
2023-11-072024-01-11970 days
2117545/2021MARCAINE SPINAL 0.5% HEAVY AMPS.BUPIVACAINE HYDROCHLORIDE NOT APPLIED ABRIDGED 2021-09-24
Application Date
2023-09-132023-10-02970 days
2127808/2021FENTANYLFENTANYL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-30
Application Date
Undefined
2137844/2021NEURO-STONEPREGABALIN/ METHYLCOBALAMINE/ FOLIC ACID/ PYRIDOXINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-01
Application Date
2024-03-182024-03-20963 days
2147832/2021MONTEMAC-5MONTELUKAST GMP CERTIFICATE AVAILABLE RECOGNITION 2021-10-01
Application Date
2023-10-102024-04-23963 days
2158230/2021MEDI-KEEL A THROAT LOZENGESCETYLPYRIDINIUM CHLORIDE+BENZOCAINE APPLIED FOR GMP ABRIDGED 2021-10-12
Application Date
2023-11-21Undefined
21611316/2021ACYCLOVIR DENK ACYCLOVIR NOT APPLIED RECOGNITION 2021-12-22
Application Date
2024-04-19Undefined
21711313/2021DICLO-DENK 50 DICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE ABRIDGED 2021-12-22
Application Date
2023-07-242023-08-08881 days
218290/2022LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE 150MG/200MG/300MGLAMIVUDINE/NEVIRAPINE/ZIDOVUDINE GMP CERTIFICATE AVAILABLE RECOGNITION 2022-01-10
Application Date
2024-03-182024-03-19862 days
2191065/2022DT-ZINCZINC SULPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-24
Application Date
2024-03-182024-04-17848 days
2202771/2022SYBRAVA 284INCLISIRAN SODIUM NOT APPLIED RECOGNITION 2022-02-28
Application Date
2024-02-042024-03-27813 days
2214585/2022PANTAKIND-40PANTOPRAZOLE SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-04-08
Application Date
2024-03-132024-03-20774 days
2226189/2022AMETAPIR-50TOPIRAMATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-05-12
Application Date
2024-03-152024-03-19740 days
2236671/2022OXCIN OPHTHALMIC SOLUTIONMOXIFLOXACIN HYDROCHLORIDE BP NOT APPLIED RECOGNITION 2022-05-23
Application Date
2022-11-022022-11-08729 days
2246672/2022OXCIN-D OPHTHALMIC SOLUTIONMOXIFLOXACIN HYDROCHLORIDE BP /DEXAMETHASONE PHOSPHATE NOT APPLIED RECOGNITION 2022-05-23
Application Date
2022-11-022022-11-08729 days
2257998/2022DAPAVELDACTIN 10MGDAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03
Application Date
2024-04-012024-04-03718 days
2268004/2022VAXATO 15MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03
Application Date
2024-03-192024-03-20718 days
2278006/2022VAXATO 20MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03
Application Date
2024-03-202024-03-21718 days
2288007/2022VAXATO 10MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03
Application Date
2024-03-222024-03-25718 days
2298008/2022DAPAVELDACTIN 5MGDAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03
Application Date
2024-04-042024-04-05718 days
23011207/2022LASTAVIN AM 10/160AMLODIPINE AND VALSARTAN USP GMP CERTIFICATE AVAILABLE RECOGNITION 2022-08-08
Application Date
2024-01-122024-01-18652 days
23112245/2022ALBENDAZOLE 400MG CHEWABLE TABLETSALBENDAZOLE APPLIED FOR GMP RECOGNITION 2022-08-29
Application Date
2023-11-23Undefined
232RWANDA-FDA23/HM/0172MomadermMometasone Furoate Cream USP 0.1% w/w GMP AVAILABLE RECOGNITION 2022-09-06
Application Date
Undefined
23313775/2022ESLOTIN 2.5MG/ML SYRUPDESLORATADINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-21
Application Date
2024-03-202024-03-26608 days
23415063/2022DEXAMETHASONE MEDISDEXAMETHASONE PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-11
Application Date
2024-03-122024-04-02588 days
23515440/2022RAYZIUM 20ESOMEPRAZOLE MAGNESIUM TRIHYDRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2022-10-18
Application Date
2024-01-042024-04-22581 days
23615445/2022TROGYL PLUS SUSPENSIONMETRONIDAZOLE/ DILOXANIDE FUROATE GMP CERTIFICATE AVAILABLE ABRIDGED 2022-10-18
Application Date
2023-08-232023-09-20581 days
23716902-2022PARACETAMOL PARACETAMOL APPLIED FOR GMP ABRIDGED 2022-11-11
Application Date
2023-11-152024-04-17557 days
23817102-2022EMITOSS-4ONDANSETRON APPLIED FOR GMP ABRIDGED 2022-11-15
Application Date
2023-09-132023-09-19553 days
23918085-2022ALVEOFACT RECOMBINANT-SF-RI NOT APPLIED RECOGNITION 2022-12-02
Application Date
2023-08-092023-08-11536 days
24018086-2022ALVEOFACT RECOMBINANT-SF-RI NOT APPLIED RECOGNITION 2022-12-02
Application Date
2023-08-092023-11-08536 days
2410181/2023BIOFULVINGRISEOFULVIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-01-06
Application Date
2024-03-272024-04-03501 days
2421993/2023COLDAMOL-P SYRUPCHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-02-13
Application Date
2024-04-25Undefined
2431994/2023HYOSPAN SYRUPHYOSCINE BUTYL BROMIDE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2023-02-13
Application Date
2024-04-26Undefined
2443028/2023RIFAPENTINERIFAPENTINE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-03-03
Application Date
2024-04-222024-04-28445 days
2453770/2023OSMOWINLACTULOSE APPLIED FOR GMP FULL ASSESSMENT 2023-03-17
Application Date
Undefined
2463771/2023SIMBRINZA BRINZOLAMIDE/ BRIMONIDINE TATRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2023-03-17
Application Date
2024-04-022024-04-28431 days
2474531/2023BRINZOX TBrinzolamide USP, Timolol Maleate BP GMP CERTIFICATE AVAILABLE RECOGNITION 2023-03-31
Application Date
Undefined
2484823/2023DEEP HEAT SPRAYMethyl salicylate, ethyl salicylate, 2-hydroxyethylsalicylate and methyl nicotinate GMP CERTIFICATE AVAILABLE ABRIDGED 2023-04-06
Application Date
2024-04-262024-05-02411 days
2495004/2023Insulin Glargine Impact Insulin Glargine NOT APPLIED ABRIDGED 2023-04-12
Application Date
2023-04-172024-04-04405 days
2505044/2023KRYXANARIBOCICLIB NOT APPLIED RECOGNITION 2023-04-13
Application Date
2024-03-282024-04-17404 days
2515041/2023ULTRAFLOXCIPROFLOXACIN NOT APPLIED RECOGNITION 2023-04-13
Application Date
2023-09-142023-09-20404 days
2525751/2023Morphine MedisMorphine Hydrochloride GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-27
Application Date
2024-03-132024-04-16390 days
253RWANDA-FDA23/HM/0076APRETUDECABOTEGRAVIR NOT APPLIED RECOGNITION 2023-05-15
Application Date
Undefined
254RWANDA-FDA23/HM/0049CETRIREN TABLETS 10MG CETRIZINE GMP AVAILABLE ABRIGDED 2023-06-08
Application Date
Undefined
255RWANDA-FDA23/HM/0138Antihist Cream MEPYRAMINE MALEATE ABBRIDGED 2023-06-14
Application Date
Undefined
256RWANDA-FDA23/HM/0036BrinzoxBrinzolamide USP APPLIED RECOGNITION 2023-06-15
Application Date
Undefined
257RWANDA-FDA23/HM/0056OMIREN CAPSULES 20 mg B/100\'SOMEPRAZOLE CAPSULES APPLIED ABRIGDED 2023-06-16
Application Date
Undefined
258RWANDA-FDA23/HM/0055MULTIREN TABLETS B/100\'SVITAMIN A + VITAMIN D3 + VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + NICOTINAMIDE APPLIED ABRIGDED 2023-06-16
Application Date
Undefined
259RWANDA-FDA23/HM/0070Adacin GelAdapalene and Clindamycin Phosphate Gel GMP AVAILABLE RECOGNITION 2023-06-30
Application Date
Undefined
260RWANDA-FDA23/HM/0087Celmac 400Celecoxib Capsule 400mg GMP AVAILABLE RECOGNITION 2023-07-06
Application Date
Undefined
261RWANDA-FDA23/HM/0091RALEF 90Etoricoxib 90 mg GMP AVAILABLE RECOGNITION 2023-07-21
Application Date
Undefined
262RWANDA-FDA23/HM/0141ASOMEX D TABLET APPLIED RECOGNITION 2023-08-09
Application Date
Undefined
263RWANDA-FDA23/HM/0158Tofacitinib Pfizer 5Tofacitinib Citrate RECOGNITION 2023-08-16
Application Date
Undefined
264RWANDA-FDA23/HM/0219LISOFLEDIPASVIR AND SOFOSBUVIR TABLETS APPLIED ABRIGDED 2023-09-20
Application Date
Undefined
265Via EmailPZ-4 PIMOZIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-09-21
Application Date
2024-05-022024-05-02243 days
266Via EmailPZ-1PIMOZIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-09-21
Application Date
2024-04-022024-05-02243 days
267Via EmailCLOM TABLETS CLOMIPRAMINE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-09-21
Application Date
Undefined
268RWANDA-FDA23/HM/0163Crisaborole Pfizer 2%Crisaborole RECOGNITION 2023-09-27
Application Date
Undefined
269RWANDA-FDA23/HM/0154Bosutinib Pfizer 400Bosutinib monohydrate RECOGNITION 2023-09-27
Application Date
Undefined
270RWANDA-FDA23/HM/0149Bosutinib Pfizer 500Bosutinib monohydrate NOT APPLIED RECOGNITION 2023-09-27
Application Date
Undefined
271RWANDA-FDA23/HM/0227Raltegravir Tablets 400mg Raltegravir Potassium (Amorphous) ABBRIDGED 2023-09-29
Application Date
Undefined
272RWANDA-FDA23/HM/0337HYORTH injectionSodium Hyaluronate Sterile Solution NOT APPLIED RECOGNITION 2023-11-03
Application Date
Undefined
273RWANDA-FDA23/HM/0430FLOXSAFE 400Moxifloxacin Tablets 400 mg GMP AVAILABLE RECOGNITION 2023-12-27
Application Date
Undefined
274RWANDA-FDA24/HM/0017UROKA PLUSTAMSULOSINE + DUTASTERIDE GMP AVAILABLE RECOGNITION 2024-01-15
Application Date
Undefined
275RWANDA-FDA23/HM/0546FERASIRO 125 DTDeferasirox RECOGNITION 2024-01-29
Application Date
Undefined
276RWANDA-FDA23/HM/0269MYCOREN SUSPENSION 100MIUNYSTATINE APPLIED ABRIGDED 2024-02-06
Application Date
Undefined
277RWANDA-FDA23/HM/0261IBUFLAM 400MG TABLETSIBUPROFEN TABLETS BP 400MG GMP AVAILABLE ABBRIDGED 2024-02-13
Application Date
Undefined
278RWANDA-FDA23/HM/0322Biofulvin 125mg tabletsGRISEOFULVIN TABLETS BP GMP AVAILABLE ABRIGDED 2024-02-13
Application Date
Undefined
279RWANDA-FDA23/HM/0314Biodox capsulesDOXYCYCLINE BP GMP AVAILABLE ABRIGDED 2024-02-13
Application Date
Undefined
280RWANDA-FDA23/HM/0302Ibuflam suspensionIBUPROFEN ORAL SUSPENSION GMP AVAILABLE ABRIGDED 2024-02-13
Application Date
Undefined
281RWANDA-FDA23/HM/0325Biofulvin 250mg tabletsGRISEOFULVINE TABLET GMP AVAILABLE ABRIGDED 2024-02-13
Application Date
Undefined
282RWANDA-FDA23/HM/0415Flutrox 150mg CapsulesFluconazole capsules NOT APPLIED RECOGNITION 2024-02-16
Application Date
Undefined
283RWANDA-FDA23/HM/0407Flutrox 200mg CapsulesFLUCONAZOLE USP NOT APPLIED RECOGNITION 2024-02-16
Application Date
Undefined
284RWANDA-FDA24/HM/0044INDOREN 25MG CAP(10*10)INDOMETHACIN 25MG GMP AVAILABLE ABRIGDED 2024-03-08
Application Date
Undefined
285RWANDA-FDA24/HM/0047CLOXAREN 250MG Caps (10*10)Cloxacillin 250 mg APPLIED ABRIGDED 2024-03-08
Application Date
Undefined
286RWANDA-FDA24/HM/0048CLOXAREN ORAL SUSPENSIONCloxacillin 125mg GMP AVAILABLE ABBRIDGED 2024-03-08
Application Date
Undefined
287RWANDA-FDA24/HM/0078BENZOSED, 5 mlMidazolam NOT APPLIED RECOGNITION 2024-03-12
Application Date
Undefined
288RWANDA-FDA23/HM/0544KETAMAX 50Ketamine Hydrochloride Injection USP 50 mg/ml, 10 ml APPLIED RECOGNITION 2024-03-15
Application Date
Undefined
289RWANDA-FDA24/HM/0061Troypofol, 20 mlPropofol Injection BP 1% w/v APPLIED RECOGNITION 2024-03-15
Application Date
Undefined
290RWANDA-FDA23/HM/0306RHEUMAC GEL GMP AVAILABLE RECOGNITION 2024-03-22
Application Date
Undefined
291RWANDA-FDA23/HM/0308LABTOL-200 TABLETS. GMP AVAILABLE ABRIGDED 2024-03-22
Application Date
Undefined
292RWANDA-FDA23/HM/0318PARATAL TABLETS. GMP AVAILABLE ABBRIDGED 2024-03-22
Application Date
Undefined
293RWANDA-FDA23/HM/0296RACYCLINE EYE OINTMENT. GMP AVAILABLE RECOGNITION 2024-03-22
Application Date
Undefined
294RWANDA-FDA24/HM/0233Irbesartan/Hydrochlorothiazide Impact 300mg/12.5 mgIrbesartan/Hydrochlorothiazide APPLIED ABRIGDED 2024-04-02
Application Date
Undefined
295RWANDA-FDA24/HM/0118Irbesartan Impact 150 mgIRBESARTAN NOT APPLIED ABRIGDED 2024-04-02
Application Date
Undefined
296RWANDA-FDA24/HM/0136DNS GMP AVAILABLE ABRIGDED 2024-04-11
Application Date
Undefined
297RWANDA-FDA24/HM/0093XALME SPASMefenamic Acid and Dicyclomine Hydrochloride Tablet GMP AVAILABLE RECOGNITION 2024-04-12
Application Date
Undefined
298VALSAR HT 160/25VALSARTAN AND HYDROCHLOROTHIAZIDE APPLIED FOR GMP RECOGNITION 2024-04-15
Application Date
2024-04-222024-04-2936 days
299VALSAR HT 80/12.5VALSARTAN AND HYDROCHLOROTHIAZIDE APPLIED FOR GMP RECOGNITION 2024-04-15
Application Date
2024-04-222024-04-2936 days
300Via emailEFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE EFAVIRENZ,LAMIVUDINE,TENOFOVIR FUMARATE APPLIED FOR GMP RECOGNITION 2024-04-15
Application Date
2024-04-232024-05-0236 days
301RWANDA-FDA24/HM/0220LEFRUSID TABLETS. GMP AVAILABLE ABRIGDED 2024-04-16
Application Date
Undefined
302RWANDA-FDA24/HM/0185KEMOXYL 500 CAPSULES. APPLIED RECOGNITION 2024-04-16
Application Date
Undefined
303RWANDA-FDA24/HM/0221CHLORPROMAZINE 100MG TABLETS. GMP AVAILABLE ABRIGDED 2024-04-16
Application Date
Undefined
304RWANDA-FDA24/HM/0203ASPIRIN 300MG TABLETS. GMP AVAILABLE ABRIGDED 2024-04-16
Application Date
Undefined
305RWANDA-FDA24/HM/0192CETRIZ SYRUP. GMP AVAILABLE ABRIGDED 2024-04-16
Application Date
Undefined
306RWANDA-FDA24/HM/0219LAEOTARIN CREAM. GMP AVAILABLE ABBRIDGED 2024-04-16
Application Date
Undefined
307RWANDA-FDA24/HM/0186LABESTEN CREAM. GMP AVAILABLE RECOGNITION 2024-04-16
Application Date
Undefined
308RWANDA-FDA24/HM/0223AMOLAB-5 TABLETS. GMP AVAILABLE ABBRIDGED 2024-04-16
Application Date
Undefined
309RWANDA-FDA24/HM/0204KEMOXYL 250 CAPSULES. GMP AVAILABLE RECOGNITION 2024-04-17
Application Date
Undefined
31012815/2017DYNACORT-18DEFLAZACORT,18MG NOT APPLIED ABRIGDED 2024-05-07
Application Date
2018-11-202018-11-2414 days