| (ANDA) 220100 | 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | SOLUTION;ORAL | 1MG/7.5ML | BIONPHARMA | 2025-09-19 | No | OTC | |
| (NDA) 220073 | 001 | ELIQUIS SPRINKLEP | APIXABAN | FOR SUSPENSION;ORAL | 0.15MG | BRISTOL | 2025-04-17 | Yes | RX | |
| (ANDA) 220042 | 001 | DEFLAZACORT | DEFLAZACORT | SUSPENSION;ORAL | 22.75MG/ML | ZYDUS LIFESCIENCES | 2025-10-03 | No | RX | AB |
| (NDA) 220020 | 001 | YEZTUGOP | LENACAPAVIR SODIUM | TABLET;ORAL | EQ 300MG BASE | GILEAD SCIENCES INC | 2025-06-18 | Yes | RX | |
| (NDA) 220018 | 001 | YEZTUGOP | LENACAPAVIR SODIUM | SOLUTION;SUBCUTANEOUS | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | GILEAD SCIENCES INC | 2025-06-18 | Yes | RX | |
| (ANDA) 220012 | 001 | COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | TABLET;ORAL | 1GM | PHARMOBEDIENT | 2025-09-15 | No | RX | AB |
| (ANDA) 219978 | 001 | DOXYCYCLINE | DOXYCYCLINE | CAPSULE;ORAL | 40MG | CHANGZHOU PHARM | 2025-10-01 | No | RX | AB |
| (NDA) 219943 | 001 | KOSELUGOP | SELUMETINIB SULFATE | GRANULE;ORAL | EQ 5MG BASE | ASTRAZENECA | 2025-09-10 | Yes | RX | |
| (NDA) 219943 | 002 | KOSELUGOP | SELUMETINIB SULFATE | GRANULE;ORAL | EQ 7.5MG BASE | ASTRAZENECA | 2025-09-10 | Yes | RX | |
| (ANDA) 219939 | 001 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | ALEMBIC | 2025-07-25 | No | RX | AB |
| (ANDA) 219939 | 002 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 200MG | ALEMBIC | 2025-07-25 | No | RX | AB |
| (ANDA) 219939 | 003 | CARBAMAZEPINE | CARBAMAZEPINE | TABLET, EXTENDED RELEASE;ORAL | 400MG | ALEMBIC | 2025-07-25 | No | RX | AB |
| (NDA) 219935 | 001 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 20MG/5ML (4MG/ML) | SAGENT | 2025-07-16 | Yes | RX | |
| (NDA) 219935 | 002 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 40MG/10ML (4MG/ML) | SAGENT | 2025-07-16 | Yes | RX | |
| (NDA) 219935 | 003 | FAMOTIDINE | FAMOTIDINE | SOLUTION;INTRAVENOUS | 200MG/50ML (4MG/ML) | SAGENT | 2025-07-16 | Yes | RX | |
| (ANDA) 219922 | 001 | PAZOPANIB HYDROCHLORIDE | PAZOPANIB HYDROCHLORIDE | TABLET;ORAL | EQ 400MG BASE | TORRENT | 2025-09-04 | No | RX | |
| (NDA) 219921 | 001 | KYXATAP | CARBOPLATIN | SOLUTION;INTRAVENOUS | 20MG/2ML (10MG/ML) | AVYXA HOLDINGS | 2025-08-08 | Yes | DISCN | |
| (NDA) 219921 | 002 | KYXATAP | CARBOPLATIN | SOLUTION;INTRAVENOUS | 80MG/8ML (10MG/ML) | AVYXA HOLDINGS | 2025-08-08 | Yes | RX | |
| (NDA) 219921 | 003 | KYXATAP | CARBOPLATIN | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | AVYXA HOLDINGS | 2025-08-08 | Yes | RX | |
| (NDA) 219920 | 001 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | DISCN | |
