Oxybutynin Chloride

Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 214415, held by Rubicon Research. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 214415 (Oxybutynin Chloride), held by Rubicon Research, was first approved by FDA on Oct 27, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 27, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 27, 2020	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


Jan 27, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Oct 27, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 214415
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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