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FDA Approval

Fosinopril Sodium

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

FDA Approval Summary

Company
Effective Date
February 5, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fosinopril(20 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fosinopril Sodium

Product Details

NDC Product Code
54868-5055
Application Number
ANDA076139
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 5, 2013
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT

Fosinopril Sodium

Product Details

NDC Product Code
54868-5182
Application Number
ANDA076139
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 5, 2013
Code: NW2RTH6T2NClass: ACTIBQuantity: 40 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT

Fosinopril Sodium

Product Details

NDC Product Code
54868-5064
Application Number
ANDA076139
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 5, 2013
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
Code: NW2RTH6T2NClass: ACTIBQuantity: 10 mg in 1 1
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
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