Oxybutynin Chloride

ANDA 76682, held by Lannett Co Inc. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 76682 (Oxybutynin Chloride), held by Lannett Co Inc, was first approved by FDA on Dec 28, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 28, 2004
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 28, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxybutynin Chloride5MG/5ML · syrup;oral	Oxybutynin Chloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 29, 2008	Supplement 2Labeling	Approved	None posted
Feb 1, 2007	Supplement 1Labeling	Approved	None posted
Dec 28, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76682
Drugs@FDA: Overview at FDA
Company: Lannett Company

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