| (NDA) 220073 | 001 | ELIQUIS SPRINKLEP | 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) 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) 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) 219674 | 001 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) | MANKIND PHARMA | 2025-05-29 | No | RX | AP |
| (ANDA) 219674 | 002 | ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | INJECTABLE;INJECTION | 100MG/10ML (10MG/ML) | MANKIND PHARMA | 2025-05-29 | No | RX | AP |
| (ANDA) 219661 | 001 | METHENAMINE HIPPURATE | METHENAMINE HIPPURATE | TABLET;ORAL | 1GM | ZYDUS LIFESCIENCES | 2025-03-10 | No | RX | AB |
| (ANDA) 219633 | 001 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | ASPIRO | 2025-06-11 | No | RX | AP |
| (ANDA) 219633 | 002 | SELENIOUS ACID | SELENIOUS ACID | SOLUTION;INTRAVENOUS | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | ASPIRO | 2025-06-11 | No | RX | AP |
| (NDA) 219616 | 001 | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | CAPSULE, TABLET;ORAL | EQ 0.8MG BASE;EQ 200MG BASE | VERASTEM INC | 2025-05-08 | Yes | RX | |
| (NDA) 219592 | 001 | GOZELLIXP | GALLIUM GA-68 GOZETOTIDE | POWDER;INTRAVENOUS | N/A | TELIX INNOVATIONS | 2025-03-20 | Yes | RX | |
