Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aizant Drug Research Solutions Pvt Ltd
Micro Labs Limited
650372951
Micro Labs Limited
Micro Labs Limited
915793658
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
42571-378Application Number
ANDA215537Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 14, 2022HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
SHELLACInactive
Code: MB5IUD6JUAClass: IACT