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FDA Approval

sevelamer carbonate

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

FDA Approval Summary

Effective Date
December 31, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sevelamer(2400 mg in 1 1)

Products2

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
0115-1366
Application Number
ANDA211316
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2020
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 2400 mg in 1 1
LEMONInactive
Code: 24RS0A988OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

sevelamer carbonate

Product Details

NDC Product Code
0115-1365
Application Number
ANDA211316
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 31, 2020
LEMONInactive
Code: 24RS0A988OClass: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693YClass: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0CClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
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