Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Suven Pharmaceuticals Limited
861468675
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Suven Pharmaceuitcals Ltd
Suven Pharmaceuticals Limited
Suven Pharmaceuticals Limited
677604288
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcium Acetate
Product Details
NDC Product Code
68022-0119Application Number
ANDA211038Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 9, 2024Calcium acetateActive
Code: Y882YXF34XClass: ACTIBQuantity: 667 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACTQuantity: 10 mg in 1 1
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACTQuantity: 6 mg in 1 1