Details for New Drug Application (NDA): 206716
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The generic ingredient in MAFENIDE ACETATE is mafenide acetate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mafenide acetate profile page.
Summary for 206716
Tradename: | MAFENIDE ACETATE |
Applicant: | Novast Labs |
Ingredient: | mafenide acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 206716
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MAFENIDE ACETATE | mafenide acetate | FOR SOLUTION;TOPICAL | 206716 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-310 | 50742-310-25 | 5 PACKET in 1 CARTON (50742-310-25) / 1 POWDER, FOR SOLUTION in 1 PACKET (50742-310-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;TOPICAL | Strength | 5% | ||||
Approval Date: | Jul 31, 2017 | TE: | RLD: | No |
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