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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) 217789 001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTABLE;INJECTION 15MG/ML CAPLIN 2023-05-10 No RX AP
(ANDA) 217789 002 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE INJECTABLE;INJECTION 30MG/ML CAPLIN 2023-05-10 No RX AP
(NDA) 217759 001 JOENJAP LENIOLISIB PHOSPHATE TABLET;ORAL EQ 70MG BASE PHARMING 2023-03-24 Yes RX
(ANDA) 217696 001 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG NOVITIUM PHARMA 2023-05-09 No RX AB
(NDA) 217660 001 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR GRANULES;ORAL 80MG, 60MG, 40MG;59.5MG VERTEX PHARMS INC 2023-04-26 Yes RX
(NDA) 217660 002 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR GRANULES;ORAL 100MG, 75MG, 50MG;75MG VERTEX PHARMS INC 2023-04-26 Yes RX
(ANDA) 217656 001 ICOSAPENT ETHYL ICOSAPENT ETHYL CAPSULE;ORAL 500MG ZYDUS 2023-04-20 No RX AB
(ANDA) 217656 002 ICOSAPENT ETHYL ICOSAPENT ETHYL CAPSULE;ORAL 1GM ZYDUS 2023-04-20 No RX AB
(NDA) 217639 001 ORSERDUP ELACESTRANT DIHYDROCHLORIDE TABLET;ORAL EQ 86MG BASE STEMLINE THERAP 2023-01-27 Yes RX
(NDA) 217639 002 ORSERDUP ELACESTRANT DIHYDROCHLORIDE TABLET;ORAL EQ 345MG BASE STEMLINE THERAP 2023-01-27 Yes RX
(ANDA) 217555 001 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 20MG SQUARE PHARMS 2023-05-03 No RX AB
(ANDA) 217555 002 NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE CAPSULE;ORAL 30MG SQUARE PHARMS 2023-05-03 No RX AB
(ANDA) 217543 001 FAMOTIDINE FAMOTIDINE TABLET;ORAL 10MG MARKSANS PHARMA 2023-03-08 No OTC
(ANDA) 217543 002 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG MARKSANS PHARMA 2023-03-08 No OTC
(ANDA) 217538 001 DEXAMETHASONE DEXAMETHASONE TABLET;ORAL 2MG BIONPHARMA INC 2023-04-26 No RX AB
(NDA) 217514 001 TAFINLARP DABRAFENIB MESYLATE TABLET, FOR SUSPENSION;ORAL EQ 10MG BASE NOVARTIS 2023-03-16 Yes RX
(NDA) 217513 001 MEKINISTP TRAMETINIB DIMETHYL SULFOXIDE SOLUTION;ORAL EQ 0.05MG BASE/ML NOVARTIS 2023-03-16 Yes RX
(ANDA) 217480 001 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 4.5354GM/7.5ML (604.72MG/ML) HAINAN POLY PHARM 2023-03-15 No RX AP
(ANDA) 217480 002 GADOBUTROL GADOBUTROL SOLUTION;INTRAVENOUS 9.0708GM/15ML (604.72MG/ML) HAINAN POLY PHARM 2023-03-15 No RX AP
(ANDA) 217478 001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE TABLET;ORAL EQ 5MG BASE BIONPHARMA INC 2023-04-04 No RX AB