MedPath
FDA Approval

VELTASSA

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

FDA Approval Summary

Company
Vifor Pharma, Inc.
DUNS: 808446087
Effective Date
November 16, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Patiromer(25.2 g in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VELTASSA

Product Details

NDC Product Code
53436-252
Application Number
NDA205739
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 10, 2023
PatiromerActive
Code: 1FQ2RY5YHHClass: ACTIMQuantity: 25.2 g in 1 1
xanthan gumInactive
Code: TTV12P4NEEClass: IACTQuantity: 0.36 g in 1 1

VELTASSA

Product Details

NDC Product Code
53436-084
Application Number
NDA205739
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 10, 2023
PatiromerActive
Code: 1FQ2RY5YHHClass: ACTIMQuantity: 8.4 g in 1 1
xanthan gumInactive
Code: TTV12P4NEEClass: IACTQuantity: 0.12 g in 1 1

VELTASSA

Product Details

NDC Product Code
53436-168
Application Number
NDA205739
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
October 10, 2023
PatiromerActive
Code: 1FQ2RY5YHHClass: ACTIMQuantity: 16.8 g in 1 1
xanthan gumInactive
Code: TTV12P4NEEClass: IACTQuantity: 0.24 g in 1 1
© Copyright 2025. All Rights Reserved by MedPath