Oxybutynin Chloride

ANDA 210717, held by Bionpharma. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 210717 (Oxybutynin Chloride), held by Bionpharma, was first approved by FDA on Dec 17, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 17, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 17, 2019	Original application	Approved	None posted

Products

3 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Sep 2, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Dec 17, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210717
Drugs@FDA: Overview at FDA
Company: Bionpharma

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