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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) 217410 001 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 1MG AJANTA PHARMA LTD 2023-01-05 No RX AB
(ANDA) 217410 002 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 2.5MG AJANTA PHARMA LTD 2023-01-05 No RX AB
(ANDA) 217410 003 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 5MG AJANTA PHARMA LTD 2023-01-05 No RX AB
(ANDA) 217410 004 FLUPHENAZINE HYDROCHLORIDE FLUPHENAZINE HYDROCHLORIDE TABLET;ORAL 10MG AJANTA PHARMA LTD 2023-01-05 No RX AB
(ANDA) 217069 001 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 10MG/ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(ANDA) 217069 002 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 50MG/5ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(ANDA) 217069 003 PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 100MG/10ML (10MG/ML) MANKIND PHARMA 2022-08-30 No RX AP1
(ANDA) 217054 001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE CAPSULE;ORAL 10MG TWI PHARMS 2022-12-27 No RX AB
(ANDA) 217038 001 KETOROLAC TROMETHAMINE KETOROLAC TROMETHAMINE TABLET;ORAL 10MG ZYDUS 2022-10-21 No RX AB
(NDA) 217003 001 IMBRUVICAP IBRUTINIB SUSPENSION;ORAL 70MG/ML PHARMACYCLICS INC 2022-08-24 Yes RX
(NDA) 216986 001 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 1.4553GM/3ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 002 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 3.63825GM/7.5ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 003 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 4.851GM/10ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 004 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 7.2765GM/15ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 005 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 14.553GM/30ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 006 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 24.255GM/50ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(NDA) 216986 007 ELUCIREMP GADOPICLENOL SOLUTION;INTRAVENOUS 48.51GM/100ML (485.1MG/ML) GUERBET 2022-09-21 Yes RX
(ANDA) 216983 001 PYRIMETHAMINE PYRIMETHAMINE TABLET;ORAL 25MG AUROBINDO PHARMA LTD 2022-10-25 No RX AB
(ANDA) 216967 001 MESALAMINE MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 375MG ALEMBIC PHARMS 2022-10-28 No RX AB
(ANDA) 216961 001 THEOPHYLLINE THEOPHYLLINE TABLET, EXTENDED RELEASE;ORAL 300MG TEVA PHARMS INC 2022-10-12 No RX AB