| (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 |
