| (NDA) 220073 | 001 | ELIQUIS SPRINKLE | APIXABAN | FOR SUSPENSION;ORAL | 0.15MG | BRISTOL | 2025-04-17 | 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) 219767 | 001 | TAMSULOSIN HYDROCHLORIDE | TAMSULOSIN HYDROCHLORIDE | CAPSULE;ORAL | 0.4MG | GRAVITI PHARMS | 2025-05-01 | No | RX | AB |
| (ANDA) 219689 | 001 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 1MG BASE | RUBICON | 2025-04-15 | No | RX | AB |
| (ANDA) 219689 | 002 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | RUBICON | 2025-04-15 | No | RX | AB |
| (ANDA) 219689 | 003 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 3MG BASE | RUBICON | 2025-04-15 | No | RX | AB |
| (ANDA) 219689 | 004 | GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | RUBICON | 2025-04-15 | No | RX | AB |
| (ANDA) 219661 | 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | TABLET;ORAL | 1GM | ZYDUS LIFESCIENCES | 2025-03-10 | No | RX | AB |
| (NDA) 219592 | 001 | GOZELLIXP | GALLIUM GA-68 GOZETOTIDE | POWDER;INTRAVENOUS | N/A | TELIX INNOVATIONS | 2025-03-20 | Yes | RX | |
| (ANDA) 219585 | 001 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | ASPIRO | 2025-05-01 | No | RX | AP |
| (ANDA) 219585 | 002 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | ASPIRO | 2025-05-01 | No | RX | AP |
| (ANDA) 219585 | 003 | ZINC SULFATE | ZINC SULFATE | SOLUTION;INTRAVENOUS | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | ASPIRO | 2025-05-01 | No | RX | AP |
| (ANDA) 219562 | 001 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | INJECTABLE;INTRAVENOUS | 500MG/100ML (5MG/ML) | CAPLIN | 2025-01-16 | No | RX | AP |
| (ANDA) 219562 | 002 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | INJECTABLE;INTRAVENOUS | 1GM/100ML (10MG/ML) | CAPLIN | 2025-01-16 | No | RX | AP |
| (ANDA) 219562 | 003 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | INJECTABLE;INTRAVENOUS | 1.5GM/100ML (15MG/ML) | CAPLIN | 2025-01-16 | No | RX | AP |
| (ANDA) 219557 | 001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.2% BASE | GLENMARK PHARMS INC | 2025-02-28 | No | OTC | |
| (ANDA) 219547 | 001 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | SUN PHARM | 2025-02-20 | No | RX | AP |
| (ANDA) 219535 | 001 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | INJECTABLE;INJECTION | 1% | ANTHEA PHARMA | 2025-04-02 | No | RX | AP |
