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FDA Approval

Atazanavir

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 25, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atazanavir(300 mg in 1 1)

Products4

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
69238-1138
Application Number
ANDA209717
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 25, 2023
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Code: 4MT4VIE29PClass: ACTIMQuantity: 300 mg in 1 1
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT

Atazanavir

Product Details

NDC Product Code
69238-1136
Application Number
ANDA209717
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 25, 2023
Code: 4MT4VIE29PClass: ACTIMQuantity: 150 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Atazanavir

Product Details

NDC Product Code
69238-1137
Application Number
ANDA209717
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 25, 2023
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Code: 4MT4VIE29PClass: ACTIMQuantity: 200 mg in 1 1
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Atazanavir

Product Details

NDC Product Code
69238-1135
Application Number
ANDA209717
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 25, 2023
Code: 4MT4VIE29PClass: ACTIMQuantity: 100 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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