Application 021738
- Type
- NDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EXTINA | KETOCONAZOLE | AEROSOL, FOAM;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-7007 | Ketaconazole | Ketaconazole | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-8136 | EXTINA | ketoconazole | Mylan Pharmaceuticals Inc. | NDA | Current |
| 40076-051 | EXTINA | ketoconazole | Prestium Pharma, Inc. | NDA | Current |