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DermOtic
DermOtic - 68791-103-20 - (fluocinolone acetonide)
Drug Information of DermOtic
| Product NDC: | 68791-103 |
| 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) |
Labeler Information of DermOtic
| Product NDC: | 68791-103 |
| Labeler Name: | Royal Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019452 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130708 |
Package Information of DermOtic
| Package NDC: | 68791-103-20 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) > 20 mL in 1 BOTTLE, DROPPER |
NDC Information of DermOtic
| NDC Code | 68791-103-20 |
| Proprietary Name | DermOtic |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) > 20 mL in 1 BOTTLE, DROPPER |
| Product NDC | 68791-103 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fluocinolone acetonide |
| Dosage Form Name | OIL |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20130708 |
| Marketing Category Name | NDA |
| Labeler Name | Royal Pharmaceuticals |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Strength Number | .11 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
