Oxybutynin Chloride

ANDA 76644, held by Pharmobedient. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 76644 (Oxybutynin Chloride), held by Pharmobedient, was first approved by FDA on Nov 9, 2006, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2006
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

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

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Jan 5, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Jan 5, 2016	Supplement 16Labeling · Standard review	Approved	None posted
Jul 26, 2013	Supplement 13Labeling · Standard review	Approved	None posted
Apr 29, 2013	Supplement 12Labeling · Standard review	Approved	None posted
Mar 1, 2011	Supplement 11Labeling	Approved	None posted
Mar 20, 2009	Supplement 9Labeling	Approved	None posted
Nov 9, 2006	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76644
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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