Application 076408
- Type
- ANDA
- Sponsor
- FOUGERA PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE | METRONIDAZOLE | CREAM;TOPICAL | 0.75% | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0323 | Metronidazole | Metronidazole | E.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0323 | Metronidazole | Metronidazole | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0323 | Metronidazole | Metronidazole | Fougera Pharmaceuticals Inc. | ANDA | Current |
| 0168-0323 | Metronidazole | Metronidazole | Fougera Pharmaceuticals Inc. | ANDA | Current |