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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

Company
Precision Dose, Inc.
DUNS: 035886746
Effective Date
September 22, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sevelamer(800 mg in 1 1)

Products1

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
68094-034
Application Number
ANDA207288
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
Microcrystalline CelluloseInactive
Code: OP1R32D61UClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
Zinc StearateInactive
Code: H92E6QA4FVClass: IACT
AmmoniaInactive
Code: 5138Q19F1XClass: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357Class: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
SevelamerActive
Code: 9YCX42I8IUClass: ACTIBQuantity: 800 mg in 1 1
DIACETYLATED MONOGLYCERIDESInactive
Code: 5Z17386USFClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
ShellacInactive
Code: 46N107B71OClass: IACT
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