Oxybutynin Chloride

ANDA 76745, held by Impax Pharms. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 76745 (Oxybutynin Chloride), held by Impax Pharms, was first approved by FDA on Nov 9, 2006, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2006
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 9, 2006	Original application	Approved	Review Letter

Products

3 strengths and forms


Oxybutynin Chloride15MG · tablet, extended release;oral	Oxybutynin Chloride	Discontinued
Oxybutynin Chloride5MG · tablet, extended release;oral	Oxybutynin Chloride	Discontinued
Oxybutynin Chloride10MG · tablet, extended release;oral	Oxybutynin Chloride	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jun 12, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Jun 12, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Sep 2, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Sep 2, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Aug 29, 2013	Supplement 10Labeling · Standard review	Approved	None posted
Jul 19, 2010	Supplement 5Labeling	Approved	None posted
May 9, 2007	Supplement 2Manufacturing	Approved	None posted
Nov 9, 2006	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76745
Drugs@FDA: Overview at FDA
Company: Impax Pharms

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