Application 077149
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TERCONAZOLE | TERCONAZOLE | SUPPOSITORY;VAGINAL | 80MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-717 | Terconazole | Terconazole | Perrigo New York Inc | ANDA | Current |
| 45802-717 | Terconazole | Terconazole | Perrigo New York Inc | ANDA | Current |
| 45802-717 | Terconazole | Terconazole | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-717 | Terconazole | Terconazole | Perrigo New York Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9011 | ORIG | 2006-04-05 |