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DermOtic - fluocinolone acetonide

Navigation: NDC > Supplier starting with: R > ROYAL PHARMACEUTICALS
Field Value
NDC Code: 68791-103
Proprietary Name: DermOtic
Suffix:
Non-Proprietary Name: fluocinolone acetonide
Dosage Form: OIL
Method: AURICULAR (OTIC)
Original Marketing Date: 09-11-2005
Category Name: NDA
Application Number: NDA019452
Labeler: ROYAL PHARMACEUTICALS
Substance Name: FLUOCINOLONE ACETONIDE
Active Numerator Strength: .11
Active Ingredient Unit: mg/mL
Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
DEA Schedule: