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FDA NDA · NDA202513

GELNIQUE 3%

Sponsor: ALLERGAN

APPLICATION
NDA202513
TYPE
NDA
ORIGINAL APPROVAL
2011-12-07
LATEST ACTION
2015-07-10
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Discontinued

Products

GELNIQUE 3% · ReferenceDiscontinued
OXYBUTYNIN 3% · GEL, METERED · TRANSDERMAL

Approval history

2015-07-10Labeling · Supplement 5 · standard — Letter ↗AP
2013-01-09Labeling · Supplement 3 · standard — Label ↗AP
2011-12-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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