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FDA Approval

Sevelamer Carbonate For Oral Suspension

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

FDA Approval Summary

Effective Date
March 24, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sevelamer(2400 mg in 1 1)

Manufacturing Establishments1

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

Zhejiang Jingxin Pharmaceutical Co., Ltd.

Hangzhou Anprime Biopharm Co., Ltd.

654209998

Products2

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

NDC Product Code
72823-302
Application Number
ANDA217319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 24, 2023
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 2400 mg in 1 1
Xanthan GumInactive
Code: TTV12P4NEEClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
SucraloseInactive
Code: 96K6UQ3ZD4Class: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT

Sevelamer Carbonate For Oral Suspension

Product Details

NDC Product Code
72823-301
Application Number
ANDA217319
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 24, 2023
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
SucraloseInactive
Code: 96K6UQ3ZD4Class: IACT
Xanthan GumInactive
Code: TTV12P4NEEClass: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRTClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
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