| Product NDC: | 43538-900 |
| Proprietary Name: | Synalar |
| Non Proprietary Name: | fluocinolone acetonide |
| Active Ingredient(s): | .25 mg/g & nbsp; fluocinolone acetonide |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 43538-900 |
| Labeler Name: | Medimetriks Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA012787 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120927 |
| Package NDC: | 43538-900-12 |
| Package Description: | 1 TUBE in 1 CARTON (43538-900-12) > 120 g in 1 TUBE |
| NDC Code | 43538-900-12 |
| Proprietary Name | Synalar |
| Package Description | 1 TUBE in 1 CARTON (43538-900-12) > 120 g in 1 TUBE |
| Product NDC | 43538-900 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fluocinolone acetonide |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20120927 |
| Marketing Category Name | NDA |
| Labeler Name | Medimetriks Pharmaceuticals, Inc. |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Strength Number | .25 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |