DermOtic - 54868-6119-0 - (fluocinolone acetonide)

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Drug Information of DermOtic

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)

Labeler Information of DermOtic

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 Information of DermOtic

Package NDC: 54868-6119-0
Package Description: 1 BOTTLE in 1 CARTON (54868-6119-0) > 20 mL in 1 BOTTLE

NDC Information of DermOtic

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]

Complete Information of DermOtic


General Information