| (ANDA) 219251 | 001 | FLUDROCORTISONE ACETATE | FLUDROCORTISONE ACETATE | TABLET;ORAL | 0.1MG | ZYDUS LIFESCIENCES | 2024-10-16 | No | RX | AB |
| (NDA) 219249 | 001 | ITOVEBI | INAVOLISIB | TABLET;ORAL | 3MG | GENENTECH INC | 2024-10-10 | Yes | RX | |
| (NDA) 219249 | 002 | ITOVEBI | INAVOLISIB | TABLET;ORAL | 9MG | GENENTECH INC | 2024-10-10 | Yes | RX | |
| (NDA) 219132 | 001 | AQNEURSA | LEVACETYLLEUCINE | FOR SUSPENSION;ORAL | 1GM/PACKET | INTRABIO | 2024-09-24 | Yes | RX | |
| (ANDA) 219116 | 001 | BUMETANIDE | BUMETANIDE | INJECTABLE;INJECTION | 0.25MG/ML | QILU PHARM HAINAN | 2024-09-19 | No | RX | AP |
| (ANDA) 219106 | 001 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | TABLET;ORAL | EQ 0.5MG BASE | INDOCO | 2024-10-29 | No | RX | AB |
| (ANDA) 219106 | 002 | VARENICLINE TARTRATE | VARENICLINE TARTRATE | TABLET;ORAL | EQ 1MG BASE | INDOCO | 2024-10-29 | No | RX | AB |
| (NDA) 219104 | 001 | PREVYMISP | LETERMOVIR | PELLETS;ORAL | 20MG/PACKET | MSD | 2024-08-30 | Yes | RX | |
| (NDA) 219104 | 002 | PREVYMISP | LETERMOVIR | PELLETS;ORAL | 120MG/PACKET | MSD | 2024-08-30 | Yes | RX | |
| (ANDA) 219055 | 001 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | AJANTA PHARMA LTD | 2024-10-17 | No | RX | AB |
| (ANDA) 219055 | 002 | FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | CAPSULE, EXTENDED RELEASE;ORAL | 150MG | AJANTA PHARMA LTD | 2024-10-17 | No | RX | AB |
| (ANDA) 219050 | 001 | EPHEDRINE SULFATE | EPHEDRINE SULFATE | SOLUTION;INTRAVENOUS | 50MG/ML (50MG/ML) | CAPLIN | 2024-07-18 | No | RX | AP |
| (NDA) 219016 | 001 | EDURANT PEDP | RILPIVIRINE HYDROCHLORIDE | TABLET, FOR SUSPENSION;ORAL | EQ 2.5MG BASE | JANSSEN PRODS | 2024-03-15 | Yes | DISCN | |
| (NDA) 219008 | 001 | LAZCLUZEP | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 80MG BASE | JANSSEN BIOTECH | 2024-08-19 | Yes | RX | |
| (NDA) 219008 | 002 | LAZCLUZEP | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 240MG BASE | JANSSEN BIOTECH | 2024-08-19 | Yes | RX | |
| (ANDA) 219002 | 001 | TRAMETINIB DIMETHYL SULFOXIDE | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 0.5MG | NOVUGEN | 2024-08-06 | No | DISCN | |
| (ANDA) 219002 | 002 | TRAMETINIB DIMETHYL SULFOXIDE | TRAMETINIB DIMETHYL SULFOXIDE | TABLET;ORAL | EQ 2MG | NOVUGEN | 2024-08-06 | No | DISCN | |
| (ANDA) 218993 | 001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 50MG/50ML (1MG/ML) | GLAND PHARMA LTD | 2024-08-12 | No | RX | AP |
| (ANDA) 218993 | 002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | GLAND PHARMA LTD | 2024-08-12 | No | RX | AP |
| (ANDA) 218991 | 001 | VALSARTAN | VALSARTAN | TABLET;ORAL | 40MG | ZYDUS LIFESCIENCES | 2024-07-22 | No | RX | AB |
