Application 077553
- Type
- ANDA
- Sponsor
- TARO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERCONAZOLE | TERCONAZOLE | SUPPOSITORY;VAGINAL | 80MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-0552 | Terconazole | Terconazole | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-0552 | Terconazole | Terconazole | G & W Laboratories, Inc. | ANDA | Current |
| 0713-0552 | Terconazole | Terconazole | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 51672-1330 | Terconazole | Terconazole | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
| 51672-1330 | Terconazole | Terconazole | Taro Pharmaceuticals U.S.A., Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 43126 | ORIG | 2013-05-02 |