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Mafenide acetate

Mafenide acetate ,USP For 5% Topical SolutionSTERILERx only

Approved
Approval ID

e48cc935-2058-48c0-9281-b8b919629493

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 26, 2017

Manufacturers
FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

Products 1

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

Mafenide acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49884-902
Application NumberANDA201511
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mafenide acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 22, 2023
FDA Product Classification

INGREDIENTS (1)

MAFENIDE ACETATEActive
Quantity: 50 g in 1 1
Code: RQ6LP6Z0WY
Classification: ACTIM

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Mafenide acetate - FDA Drug Approval Details