Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019599

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NAFTIN (NAFTIFINE HYDROCHLORIDE)
2%
Marketing Status: Prescription

Active Ingredient: NAFTIFINE HYDROCHLORIDE
Proprietary Name: NAFTIN
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019599
Product Number: 002
Approval Date: Jan 13, 2012
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

NAFTIN (NAFTIFINE HYDROCHLORIDE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: NAFTIFINE HYDROCHLORIDE
Proprietary Name: NAFTIN
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019599
Product Number: 001
Approval Date: Feb 29, 1988
Applicant Holder Full Name: SEBELA IRELAND LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information