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FDA Approval

Naftin

CompanyMerz Pharmaceuticals, LLC (DUNS: 126209282)

Effective Date

April 25, 2013

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Naftifine(10 mg in 1 g)

Products (1)

Naftin

NDC Product Code

0259-4126

Application Number

NDA019599

Marketing Category

NDA (C73594)

Route of Administration

TOPICAL

Effective Date

April 25, 2013

Ingredients

NaftifineActive

Code: 25UR9N9041Class: ACTIBQuantity: 10 mg in 1 g

WaterInactive

Code: 059QF0KO0RClass: IACT

Isopropyl MyristateInactive

Code: 0RE8K4LNJSClass: IACT

Stearyl AlcoholInactive

Code: 2KR89I4H1YClass: IACT

Polysorbate 60Inactive

Code: CAL22UVI4MClass: IACT

Cetyl AlcoholInactive

Code: 936JST6JCNClass: IACT

Cetyl Esters WaxInactive

Code: D072FFP9GUClass: IACT

Sorbitan MonostearateInactive

Code: NVZ4I0H58XClass: IACT

Benzyl AlcoholInactive

Code: LKG8494WBHClass: IACT

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