Application 213264
- Type
- ANDA
- Sponsor
- TASMAN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | OIL/DROPS;OTIC | 0.01% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72641-002 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops) | Fluocinolone Acetonide Oil, 0.01% (Ear Drops) | Tasman Pharma Inc. | ANDA | Current |