Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Unit Dose Services
831995316
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unit Dose Services
Unit Dose Services
Unit Dose Services
831995316
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
50436-3138Application Number
ANDA077222Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 25, 2011FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT