MedPath
FDA Approval

Sevelamer Carbonate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Winthrop U.S, a business of sanofi-aventis U.S. LLC
DUNS: 824676584
Effective Date
December 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sevelamer(800 mg in 1 1)

Manufacturing Establishments5

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Reed-Lane, Inc.

Winthrop U.S, a business of sanofi-aventis U.S. LLC

001819879

EUROAPI UK LIMITED

Winthrop U.S, a business of sanofi-aventis U.S. LLC

229522842

Eurofins Biopharma Product Testing Ireland Limited

Winthrop U.S, a business of sanofi-aventis U.S. LLC

238239933

Rovi Pharma Industrial Services SA

Winthrop U.S, a business of sanofi-aventis U.S. LLC

462117953

Genzyme Ireland Limited

Winthrop U.S, a business of sanofi-aventis U.S. LLC

985127419

Products4

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
0955-1050
Application Number
NDA022127
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
December 7, 2023
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1

Sevelamer Carbonate

Product Details

NDC Product Code
0955-1052
Application Number
NDA022318
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
December 7, 2023
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 0.8 g in 1 1

Sevelamer Carbonate

Product Details

NDC Product Code
0955-1054
Application Number
NDA022318
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
December 7, 2023
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 2.4 g in 1 1

Sevelamer Carbonate

Product Details

NDC Product Code
0955-1057
Application Number
NDA022127
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
December 7, 2023
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
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