Application 015296
- Type
- NDA
- Sponsor
- MEDIMETRIKS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SYNALAR | FLUOCINOLONE ACETONIDE | SOLUTION;TOPICAL | 0.01% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43538-920 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-920 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-920 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-920 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-920 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-921 | Synalar TS | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-921 | Synalar TS | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-921 | Synalar TS | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-921 | Synalar TS | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-921 | Synalar TS | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 52565-012 | Fluocinolone Acetonide | Fluocinolone Acetonide | Teligent Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70350-5201 | NOXIPAK | FLUOCINOLONE ACETONIDE and UREA | SOLUTECH PHARMACEUTICALS LLC | NDA AUTHORIZED GENERIC | Current |
| 70350-5218 | XILAPAK | FLUOCINOLONE ACETONIDE | SOLUTECH PHARMACEUTICALS LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10859 | SUPPL | 2012-11-26 |
| 12958 | SUPPL | 2012-11-21 |