Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
InvaGen Pharmaceuticals Inc.
165104469
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
InvaGen Pharmaceuticals Inc.
Exelan Pharmaceuticals Inc.
InvaGen Pharmaceuticals Inc.
080334903
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sevelamer carbonate
Product Details
NDC Product Code
76282-407Application Number
ANDA203860Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 8, 2017HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT