Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Hetero Labs Limited Unit III
Camber Pharmaceuticals, Inc.
676162024
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atazanavir
Product Details
NDC Product Code
31722-653Application Number
ANDA212278Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 2, 2022MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 150 mg in 1 1
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
Atazanavir
Product Details
NDC Product Code
31722-655Application Number
ANDA212278Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 2, 2022CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 300 mg in 1 1
Atazanavir
Product Details
NDC Product Code
31722-654Application Number
ANDA212278Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 2, 2022CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 200 mg in 1 1