| (NDA) 220073 | 001 | ELIQUIS SPRINKLEP | APIXABAN | FOR SUSPENSION;ORAL | 0.15MG | BRISTOL | 2025-04-17 | Yes | RX | |
| (NDA) 220020 | 001 | YEZTUGO | LENACAPAVIR SODIUM | TABLET;ORAL | EQ 300MG BASE | GILEAD SCIENCES INC | 2025-06-18 | Yes | RX | |
| (NDA) 220018 | 001 | YEZTUGO | LENACAPAVIR SODIUM | SOLUTION;SUBCUTANEOUS | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | GILEAD SCIENCES INC | 2025-06-18 | 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 |
| (NDA) 219847 | 001 | ARYNTAP | LISDEXAMFETAMINE DIMESYLATE | SOLUTION;ORAL | 10MG/ML | AZURITY | 2025-06-16 | Yes | RX | |
| (ANDA) 219777 | 001 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 1GM/2ML (500MG/ML) | ASPIRO | 2025-05-28 | No | RX | AP |
| (ANDA) 219777 | 002 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 5GM/10ML (500MG/ML) | ASPIRO | 2025-05-28 | No | RX | AP |
| (ANDA) 219777 | 003 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 10GM/20ML (500MG/ML) | ASPIRO | 2025-05-28 | No | RX | AP |
| (ANDA) 219777 | 004 | MAGNESIUM SULFATE | MAGNESIUM SULFATE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 25GM/50ML (500MG/ML) | ASPIRO | 2025-05-28 | No | RX | AP |
| (ANDA) 219775 | 001 | ACETAZOLAMIDE SODIUM | ACETAZOLAMIDE SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | GLAND | 2025-06-17 | No | RX | AP |
| (ANDA) 219767 | 001 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.4MG | GRAVITI PHARMS | 2025-05-01 | No | RX | AB |
| (NDA) 219713 | 001 | IBTROZIP | TALETRECTINIB ADIPATE | CAPSULE;ORAL | EQ 200MG BASE | NUVATION | 2025-06-11 | Yes | RX | |
| (ANDA) 219701 | 001 | SODIUM BICARBONATE | SODIUM BICARBONATE | INJECTABLE;INJECTION | 1MEQ/ML | ANTHEA PHARMA | 2025-06-26 | No | RX | AP |
| (ANDA) 219699 | 001 | LACOSAMIDE | LACOSAMIDE | SOLUTION;ORAL | 10MG/ML | AJENAT PHARMS | 2025-06-26 | No | RX | AA |
| (ANDA) 219689 | 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | RUBICON | 2025-04-15 | No | RX | AB |
