Sevelamer Carbonate For Oral Suspension
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 suspensionInitial U.S. Approval: 2000
Approved
Approval ID
8ef0cb12-e9f6-4865-9158-02c8cc50a511
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Hangzhou Anprime Biopharm Co., Ltd.
DUNS: 550852756
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sevelamer Carbonate For Oral Suspension
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72823-302
Application NumberANDA217319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sevelamer Carbonate For Oral Suspension
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (5)
Sevelamer CarbonateActive
Quantity: 2400 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Sevelamer Carbonate For Oral Suspension
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72823-301
Application NumberANDA217319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sevelamer Carbonate For Oral Suspension
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2023
FDA Product Classification
INGREDIENTS (5)
Sevelamer CarbonateActive
Quantity: 800 mg in 1 1
Code: 9YCX42I8IU
Classification: ACTIB
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT