Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Preferred Pharmaceuticals, Inc.
791119022
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
Preferred Pharmaceuticals, Inc.
791119022
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
68788-7717Application Number
ANDA077222Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 15, 2023FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT