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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
September 25, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fosinopril(40 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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
50090-4743
Application Number
ANDA205670
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 1, 2017
Code: NW2RTH6T2NClass: ACTIBQuantity: 40 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
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