Application 077547
- Type
- ANDA
- Sponsor
- TOLMAR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METRONIDAZOLE | METRONIDAZOLE | GEL;TOPICAL | 0.75% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1474 | Metronidazole | Metronidazole | Impax Generics | ANDA | Current |
| 0115-1474 | Metronidazole | Metronidazole | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 42254-069 | Metronidazole | Metronidazole | Rebel Distributors Corp | ANDA | Current |