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Mafenide Acetate

Mafenide Acetate for Topical Solution USP, 5% STERILE Rx Only

Approved
Approval ID

3f397e17-d14d-4a8d-a44c-6f81cd9a7abd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 5, 2023

Manufacturers
FDA

Ingenus Pharmaceuticals, LLC

DUNS: 833250017

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 Code50742-310
Application NumberANDA206716
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mafenide Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2023
FDA Product Classification

INGREDIENTS (1)

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

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Mafenide Acetate - FDA Drug Approval Details