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.
Digoxin
Product Details
NDC Product Code
71335-9610Application Number
ANDA076363Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 3, 2023DigoxinActive
Code: 73K4184T59Class: ACTIBQuantity: 125 ug in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT