Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Worldwide DMCC
557951127
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Worldwide DMCC
863362789
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
70710-1051Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 15, 2023AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 200 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ATAZANAVIR
Product Details
NDC Product Code
70710-1052Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 15, 2023PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 300 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ATAZANAVIR
Product Details
NDC Product Code
70710-1050Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 15, 2023D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 150 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT