| (NDA) 220073 | 001 | ELIQUIS SPRINKLEP | APIXABAN | FOR SUSPENSION;ORAL | 0.15MG | BRISTOL | 2025-04-17 | Yes | RX | |
| (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) 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 | |
| (NDA) 219920 | 001 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | RX | |
| (NDA) 219920 | 002 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | RX | |
| (NDA) 219920 | 003 | AVGEMSI | GEMCITABINE HYDROCHLORIDE | SOLUTION;INTRAVENOUS | EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) | AVYXA HOLDINGS | 2025-06-27 | Yes | RX | |
| (ANDA) 219883 | 001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 40MG/20ML (2MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | RX | AP |
| (ANDA) 219883 | 002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 150MG/30ML (5MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | RX | AP |
| (ANDA) 219883 | 003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 200MG/20ML (10MG/ML) | ANTHEA PHARMA | 2025-03-21 | No | RX | AP |
| (ANDA) 219863 | 001 | FAMOTIDINE | FAMOTIDINE | FOR SUSPENSION;ORAL | 40MG/5ML | MSN | 2025-07-24 | No | RX | AB |
| (NDA) 219847 | 001 | ARYNTAP | LISDEXAMFETAMINE DIMESYLATE | SOLUTION;ORAL | 10MG/ML | AZURITY | 2025-06-16 | Yes | RX | |
| (NDA) 219843 | 001 | ATMEKSI | METHOCARBAMOL | SUSPENSION;ORAL | 750MG/5ML | ROSEMONT PHARMS | 2025-07-30 | Yes | RX | |
| (NDA) 219839 | 001 | ZEGFROVYP | SUNVOZERTINIB | TABLET;ORAL | 150MG | DIZAL JIANGSU | 2025-07-02 | Yes | RX | |
| (NDA) 219839 | 002 | ZEGFROVYP | SUNVOZERTINIB | TABLET;ORAL | 200MG | DIZAL JIANGSU | 2025-07-02 | Yes | RX | |
