Application 012787
- Type
- NDA
- Sponsor
- MEDIMETRIKS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | SYNALAR | FLUOCINOLONE ACETONIDE | CREAM;TOPICAL | 0.025% | Yes | Yes |
| 004 | SYNALAR | FLUOCINOLONE ACETONIDE | CREAM;TOPICAL | 0.01% | Yes | Yes |
| 005 | SYNALAR | FLUOCINOLONE ACETONIDE | CREAM;TOPICAL | 0.025% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0713-0324 | Fluocinolone Acetonide | Fluocinolone Acetonide | Cosette Pharmaceuticals, Inc. | NDA | Current |
| 43538-900 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-901 | Synalar | Fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 52565-020 | Fluocinolone Acetonide | Fluocinolone Acetonide | Teligent Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
| 52565-031 | Fluocinolone Acetonide | Fluocinolone Acetonide | Teligent Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 10823 | SUPPL | 2013-04-09 |
| 10822 | SUPPL | 2013-04-01 |