Application 202847
- Type
- ANDA
- Sponsor
- PERRIGO ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | OIL;TOPICAL | 0.01% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-887 | fluocinolone acetonide | fluocinolone acetonide | Perrigo New York Inc | ANDA | Current |
| 45802-887 | fluocinolone acetonide | fluocinolone acetonide | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-887 | fluocinolone acetonide | fluocinolone acetonide | Perrigo New York Inc | ANDA | Current |
| 63629-8655 | fluocinolone acetonide | fluocinolone acetonide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8655 | fluocinolone acetonide | fluocinolone acetonide | Bryant Ranch Prepack | ANDA | Current |
| 63629-8655 | fluocinolone acetonide | fluocinolone acetonide | Bryant Ranch Prepack | ANDA | Current |