Application 200923
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GYNAZOLE-1 | BUTOCONAZOLE NITRATE | CREAM;VAGINAL | 2% | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-396 | gynazole 1 | butoconazole nitrate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-396 | gynazole 1 | butoconazole nitrate | Perrigo New York Inc | ANDA | Current |
| 45802-396 | gynazole 1 | butoconazole nitrate | Perrigo New York Inc | ANDA | Current |