Application 073580
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMVERM | MEBENDAZOLE | TABLET, CHEWABLE;ORAL | 100MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64896-669 | Emverm | mebendazole | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-669 | Emverm | mebendazole | Impax Specialty Pharma | ANDA | Current |
| 64896-669 | Emverm | mebendazole | Amneal Pharmaceuticals LLC | ANDA | Current |
| 64896-669 | Emverm | mebendazole | Amneal Pharmaceuticals LLC | ANDA | Current |