Registrants (1)
Cipla USA Inc.
078719707
Manufacturing Establishments (2)
CIPLA LIMITED KURKUMBH
EXELAN PHARMACEUTICALS INC.
Cipla USA Inc.
917066446
InvaGen Pharmaceuticals, Inc
EXELAN PHARMACEUTICALS INC.
Cipla USA Inc.
080334903
Products (2)
darunavir
76282-737
ANDA206288
ANDA (C73584)
ORAL
January 22, 2024
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DarunavirActive
Code: KPC4NRB25LClass: ACTIMQuantity: 600 mg in 1 1
darunavir
76282-738
ANDA206288
ANDA (C73584)
ORAL
January 22, 2024
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
DarunavirActive
Code: KPC4NRB25LClass: ACTIMQuantity: 800 mg in 1 1