Manufacturing Establishments (1)
Amneal Pharmaceuticals Private Limited
Amneal Pharmaceuticals NY LLC
650762060
Products (2)
Darunavir
60219-1144
ANDA212493
ANDA (C73584)
ORAL
December 15, 2023
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 600 mg in 1 1
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Darunavir
60219-1145
ANDA212493
ANDA (C73584)
ORAL
December 15, 2023
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 800 mg in 1 1
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT