Application 021385
- Type
- NDA
- Sponsor
- BAUSCH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERTACZO | SERTACONAZOLE NITRATE | CREAM;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Bausch Health US LLC | NDA | Current |
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Bausch Health US, LLC | NDA | Current |
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Bausch Health US LLC | NDA | Current |
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Valeant Pharmaceuticals North America LLC | NDA | Current |
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Bausch Health US, LLC | NDA | Current |
| 0187-5115 | Ertaczo | Sertaconazole Nitrate | Bausch Health Americas, Inc. | NDA | Current |
| 21695-454 | ERTACZO | ERTACZO | Rebel Distributors Corp. | ANDA | Current |