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FDA NDA · NDA022204

GELNIQUE

Sponsor: ABBVIE

APPLICATION
NDA022204
TYPE
NDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2017-10-25
ROUTE
TRANSDERMAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

GELNIQUE · ReferenceDiscontinued
OXYBUTYNIN CHLORIDE 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TRANSDERMAL

Approval history

2017-10-25Labeling · Supplement 10 · standard — Label ↗AP
2015-08-04Manufacturing (CMC) · Supplement 8 · standardAP
2015-07-10Labeling · Supplement 9 · standard — Letter ↗AP
2013-08-12Manufacturing (CMC) · Supplement 7 · standardAP
2012-10-10Labeling · Supplement 6 · standard — Label ↗AP
2011-01-31Labeling · Supplement 4 · standard — Label ↗AP
2009-01-27Type 3 - New Dosage Form · Original · standard — Review ↗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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