Application 202044
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TINIDAZOLE | TINIDAZOLE | TABLET;ORAL | 250MG | No | No |
| 002 | TINIDAZOLE | TINIDAZOLE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-550 | Tinidazole | Tinidazole | Novel Laboratories, Inc. | ANDA | Current |
| 40032-551 | Tinidazole | Tinidazole | Novel Laboratories, Inc. | ANDA | Current |
| 43386-550 | Tinidazole | Tinidazole | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-550 | Tinidazole | Tinidazole | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-551 | Tinidazole | Tinidazole | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-551 | Tinidazole | Tinidazole | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 63629-8386 | Tinidazole | Tinidazole | Bryant Ranch Prepack | ANDA | Current |