Assyro AI

Orange Book product · Brand (NDA)

OXYTROL

OXYBUTYNIN

Brand (NDA)NDA 021351RX ALLERGAN
View OXYBUTYNIN familyOpen on FDA Orange Book

At a glance

Feb 26, 2003

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 26, 2003

    23 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OXYBUTYNIN

Strength

3.9MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 021351

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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