sevelamer carbonate
These highlights do not include all the information needed to use SEVELAMER CARBONATE FOR ORAL SUSPENSION safely and effectively. See full prescribing information for SEVELAMER CARBONATE FOR ORAL SUSPENSION . SEVELAMER CARBONATE for oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
da5239fe-060b-4469-95ac-173adec43b9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2020
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sevelamer carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1366
Application NumberANDA211316
Product Classification
M
Marketing Category
C73584
G
Generic Name
sevelamer carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (7)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 2400 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
LEMONInactive
Code: 24RS0A988O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
sevelamer carbonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1365
Application NumberANDA211316
Product Classification
M
Marketing Category
C73584
G
Generic Name
sevelamer carbonate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (7)
LEMONInactive
Code: 24RS0A988O
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SEVELAMER CARBONATEActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
PROPYLENE GLYCOL ALGINATEInactive
Code: 26CD3J2R0C
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT