Application 019452
- Type
- NDA
- Sponsor
- HILL DERMAC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DERMA-SMOOTHE/FS | FLUOCINOLONE ACETONIDE | OIL;TOPICAL | 0.01% | Yes | Yes |
| 002 | DERMA-SMOOTHE/FS | FLUOCINOLONE ACETONIDE | OIL;TOPICAL | 0.01% | Yes | Yes |
| 003 | DERMOTIC | FLUOCINOLONE ACETONIDE | OIL/DROPS;OTIC | 0.01% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13925-506 | Fluocinolone Acetonide | fluocinolone acetonide | Seton Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 13925-507 | Fluocinolone Acetonide | fluocinolone acetonide | Seton Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 13925-508 | Fluocinolone acetonide 0.01% | fluocinolone acetonide | Seton Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 68791-101 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-101 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-101 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-102 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-102 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-102 | Derma-Smoothe/FS | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
| 68791-103 | DermOtic | fluocinolone acetonide | Royal Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79529 | SUPPL | 2024-09-03 |
| 79522 | SUPPL | 2024-09-03 |
| 63488 | SUPPL | 2020-06-12 |
| 63432 | SUPPL | 2020-06-08 |
| 51066 | SUPPL | 2017-12-07 |
| 17407 | SUPPL | 2005-11-18 |
| 1330 | SUPPL | 2005-11-18 |
| 1327 | SUPPL | 2005-11-18 |
| 33750 | SUPPL | 2005-11-17 |
| 33749 | SUPPL | 2005-11-17 |
| 11506 | SUPPL | 2005-11-17 |
| 33748 | SUPPL | 2003-05-29 |
| 1329 | SUPPL | 2003-05-29 |
| 20244 | SUPPL | 2001-10-10 |
| 11507 | SUPPL | 2001-10-10 |
| 1328 | SUPPL | 2001-10-10 |
| 33747 | SUPPL | 1999-08-18 |
| 20243 | SUPPL | 1999-08-18 |
| 1326 | SUPPL | 1999-08-18 |
| 64237 | ORIG | 1900-01-01 |
| 64236 | ORIG | 1900-01-01 |
| 64235 | ORIG | 1900-01-01 |