Application 212646
- Type
- ANDA
- Sponsor
- ALEOR DERMACEUTICALS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | METRONIDAZOLE | METRONIDAZOLE | GEL;TOPICAL | 1% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62332-630 | Metronidazole | Metronidazole | Alembic Pharmaceuticals, Inc. | ANDA | Current |
| 62332-630 | Metronidazole | Metronidazole | Alembic Pharmaceuticals, Inc. | ANDA | Current |
| 62332-630 | Metronidazole | Metronidazole | Alembic Pharmaceuticals, Inc. | ANDA | Current |
| 71589-014 | METRONIDAZOLE | METRONIDAZOLE | Aleor Dermaceuticals Limited | ANDA | Current |
| 71589-014 | METRONIDAZOLE | METRONIDAZOLE | Aleor Dermaceuticals Limited | ANDA | Current |