Application 091282
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUOCINONIDE | FLUOCINONIDE | CREAM;TOPICAL | 0.1% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68462-505 | Fluocinonide | Fluocinonide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-505 | Fluocinonide | Fluocinonide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-505 | Fluocinonide | Fluocinonide | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68788-7364 | Fluocinonide | Fluocinonide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7364 | Fluocinonide | Fluocinonide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7364 | Fluocinonide | Fluocinonide | Preferred Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31521 | ORIG | 2014-07-15 |