Product NDC: | 54868-6119 |
Proprietary Name: | DermOtic |
Non Proprietary Name: | fluocinolone acetonide |
Active Ingredient(s): | .11 mg/mL & nbsp; fluocinolone acetonide |
Administration Route(s): | AURICULAR (OTIC) |
Dosage Form(s): | OIL |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-6119 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA019452 |
Marketing Category: | NDA |
Start Marketing Date: | 20100716 |
Package NDC: | 54868-6119-0 |
Package Description: | 1 BOTTLE in 1 CARTON (54868-6119-0) > 20 mL in 1 BOTTLE |
NDC Code | 54868-6119-0 |
Proprietary Name | DermOtic |
Package Description | 1 BOTTLE in 1 CARTON (54868-6119-0) > 20 mL in 1 BOTTLE |
Product NDC | 54868-6119 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fluocinolone acetonide |
Dosage Form Name | OIL |
Route Name | AURICULAR (OTIC) |
Start Marketing Date | 20100716 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | FLUOCINOLONE ACETONIDE |
Strength Number | .11 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |