Application 211815
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOCINONIDE ACETONIDE | FLUOCINOLONE ACETONIDE | OIL/DROPS;OTIC | 0.01% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-185 | fluocinolone acetonide | fluocinolone acetonide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |