Application 019832
- Type
- NDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 003 | SULFAMYLON | MAFENIDE ACETATE | FOR SOLUTION;TOPICAL | 5% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51079-624 | Sulfamylon | mafenide acetate | Mylan Institutional Inc. | NDA | Current |
| 51079-624 | Sulfamylon | mafenide acetate | Mylan Institutional Inc. | NDA | Current |
| 51079-624 | Sulfamylon | mafenide acetate | Mylan Institutional Inc. | NDA | Current |
| 51079-624 | Sulfamylon | mafenide acetate | Mylan Institutional Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 19273 | SUPPL | 2001-07-12 |
| 19272 | SUPPL | 2001-07-12 |
| 41045 | ORIG | 1999-01-06 |
| 33997 | ORIG | 1998-06-05 |
| 1659 | ORIG | 1998-06-05 |