Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
71335-0726Application Number
ANDA205670Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 1, 2017FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT