Application 013960
- Type
- NDA
- Sponsor
- MEDIMETRIKS PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SYNALAR | FLUOCINOLONE ACETONIDE | OINTMENT;TOPICAL | 0.025% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43538-910 | Synalar | fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 43538-911 | Synalar | Fluocinolone acetonide | Medimetriks Pharmaceuticals, Inc. | NDA | Current |
| 52565-013 | Fluocinolone Acetonide | Fluocinolone Acetonide | Teligent Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |