Assyro AI

Orange Book product · Brand (NDA)

DETROL LA

TOLTERODINE TARTRATE

Brand (NDA)NDA 021228TE ABRX UPJOHN

At a glance

Dec 22, 2000

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 22, 2000

    25 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TOLTERODINE TARTRATE

Strength

2MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

NDA 021228

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.