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FDA NDA · NDA204286

NAFTIN

naftifine hydrochloride

Sponsor: LEGACY

APPLICATION
NDA204286
TYPE
NDA
ORIGINAL APPROVAL
2013-06-27
LATEST ACTION
2020-04-09
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

NAFTIN · ReferencePrescription
NAFTIFINE HYDROCHLORIDE 2% · GEL · TOPICAL

Approval history

2020-04-09Labeling · Supplement 4 · standard — Letter ↗AP
2018-04-30Labeling · Supplement 3 · standard — Label ↗AP
2014-10-10Efficacy · Supplement 1 · standard — Label ↗AP
2014-09-24Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2013-06-27Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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