Application 016763
- Type
- NDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SULFAMYLON | MAFENIDE ACETATE | CREAM;TOPICAL | EQ 85MG BASE/GM | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16571-723 | SULFAMYLON | mafenide acetate | Rising Pharma Holdings, Inc. | NDA | Current |
| 51079-623 | Sulfamylon | Mafenide Acetate | Mylan Institutional Inc. | NDA | Current |
| 51079-623 | Sulfamylon | Mafenide Acetate | Mylan Institutional Inc. | NDA | Current |