← FDA DRUG APPROVALS

FDA NDA · NDA021946

XOLEGEL

Sponsor: INA PHARMS

APPLICATION
NDA021946
TYPE
NDA
ORIGINAL APPROVAL
2006-07-28
LATEST ACTION
2019-12-26
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

XOLEGEL · ReferenceDiscontinued
KETOCONAZOLE 2% · GEL · TOPICAL

Approval history

2019-12-26Labeling · Supplement 7 · standard — Letter ↗AP
2013-02-27Manufacturing (CMC) · Supplement 6 · standardAP
2012-05-10Labeling · Supplement 5 · unknown — Label ↗AP
2010-12-06Labeling · Supplement 4 · unknown — Label ↗AP
2009-12-30Labeling · Supplement 3 · standard — Letter ↗AP
2008-12-19Manufacturing (CMC) · Supplement 2 — Label ↗AP
2006-07-28Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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