Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Lifesciences Limited
863362789
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
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
70771-1592Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 13, 2022AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 200 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ATAZANAVIR
Product Details
NDC Product Code
70771-1591Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 13, 2022AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 150 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ATAZANAVIR
Product Details
NDC Product Code
70771-1593Application Number
ANDA210575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 13, 2022AtazanavirActive
Code: 4MT4VIE29PClass: ACTIMQuantity: 300 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT