Manufacturing Establishments (1)
Hetero Labs Limited Unit III
Camber Pharmaceuticals, Inc.
676162024
Products (2)
Darunavir
31722-567
ANDA202083
ANDA (C73584)
ORAL
October 5, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 400 mg in 1 1
Darunavir
31722-568
ANDA202083
ANDA (C73584)
ORAL
October 5, 2023
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DarunavirActive
Code: YO603Y8113Class: ACTIBQuantity: 600 mg in 1 1