Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
MSN LABORATORIES PRIVATE LIMITED
Novadoz Pharmaceuticals LLC
650786952
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Darunavir
Product Details
NDC Product Code
72205-185Application Number
ANDA215389Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 29, 2023SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 800 mg in 1 1
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Darunavir
Product Details
NDC Product Code
72205-184Application Number
ANDA215389Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 29, 2023DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 600 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT