Details for New Drug Application (NDA): 201511
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NDA 201511 describes MAFENIDE ACETATE, which is a drug marketed by Endo Operations and Novast Labs and is included in two NDAs. It is available from two suppliers. Additional details are available on the MAFENIDE ACETATE profile page.
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.
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 201511
| Tradename: | MAFENIDE ACETATE |
| Applicant: | Endo Operations |
| Ingredient: | mafenide acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MAFENIDE ACETATE | mafenide acetate | FOR SOLUTION;TOPICAL | 201511 | ANDA | Par Pharmaceutical, Inc. | 49884-902 | 49884-902-78 | 5 PACKET in 1 CARTON (49884-902-78) / 1 POWDER, FOR SOLUTION in 1 PACKET (49884-902-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;TOPICAL | Strength | 5% | ||||
| Approval Date: | Feb 12, 2013 | TE: | RLD: | No | |||||
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