Gelnique 3%

NDA 202513, held by Allergan. Oxybutynin.

As of Nov 14, 2026, NDA 202513 (Gelnique 3%), held by Allergan, was first approved by FDA on Dec 7, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 7, 2011
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 7, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Gelnique 3%3% · gel, metered;transdermal	Oxybutynin	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jul 10, 2015	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 9, 2013	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 7, 2011	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202513
Drugs@FDA: Overview at FDA
Company: Allergan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters