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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(ANDA) 215654 001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML GLAND PHARMA LTD 2021-08-04 No RX AP
(ANDA) 215506 001 PYRIMETHAMINE PYRIMETHAMINE TABLET;ORAL 25MG TEVA PHARMS 2021-08-13 No RX AB
(NDA) 215498 001 BYLVAYP ODEVIXIBAT CAPSULE, PELLETS;ORAL 0.2MG ALBIREO 2021-07-20 Yes RX
(NDA) 215498 002 BYLVAYP ODEVIXIBAT CAPSULE;ORAL 0.4MG ALBIREO 2021-07-20 Yes RX
(NDA) 215498 003 BYLVAYP ODEVIXIBAT CAPSULE, PELLETS;ORAL 0.6MG ALBIREO 2021-07-20 Yes RX
(NDA) 215498 004 BYLVAYP ODEVIXIBAT CAPSULE;ORAL 1.2MG ALBIREO 2021-07-20 Yes RX
(ANDA) 215486 001 ACETAMINOPHEN ACETAMINOPHEN TABLET, EXTENDED RELEASE;ORAL 650MG MARKSANS PHARMA 2021-08-25 No OTC
(ANDA) 215414 001 TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG ASCENT PHARMS INC 2021-08-26 No RX AB
(ANDA) 215414 002 TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG ASCENT PHARMS INC 2021-08-26 No RX AB
(ANDA) 215414 003 TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG ASCENT PHARMS INC 2021-08-26 No RX AB
(ANDA) 215414 004 TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG ASCENT PHARMS INC 2021-08-26 No RX AB
(ANDA) 215409 001 PENICILLAMINE PENICILLAMINE CAPSULE;ORAL 250MG AGGREGA 2021-08-23 No RX AB
(NDA) 215383 001 WELIREG BELZUTIFAN TABLET;ORAL 40MG MERCK SHARP DOHME 2021-08-13 Yes RX
(NDA) 215341 001 KERENDIAP FINERENONE TABLET;ORAL 10MG BAYER HLTHCARE 2021-07-09 Yes RX
(NDA) 215341 002 KERENDIAP FINERENONE TABLET;ORAL 20MG BAYER HLTHCARE 2021-07-09 Yes RX
(ANDA) 215316 001 DAPTOMYCIN DAPTOMYCIN POWDER;INTRAVENOUS 500MG/VIAL QILU 2021-08-24 No RX AP
(NDA) 215256 001 WEGOVYP SEMAGLUTIDE SOLUTION;SUBCUTANEOUS 0.25MG/0.5ML (0.25MG/0.5ML) NOVO 2021-06-04 Yes RX
(NDA) 215256 002 WEGOVYP SEMAGLUTIDE SOLUTION;SUBCUTANEOUS 0.5MG/0.5ML (0.5MG/0.5ML) NOVO 2021-06-04 Yes RX
(NDA) 215256 003 WEGOVYP SEMAGLUTIDE SOLUTION;SUBCUTANEOUS 1MG/0.5ML (1MG/0.5ML) NOVO 2021-06-04 Yes RX
(NDA) 215256 004 WEGOVYP SEMAGLUTIDE SOLUTION;SUBCUTANEOUS 1.7MG/0.75ML (1.7MG/0.75ML) NOVO 2021-06-04 Yes RX