🇺🇸 Urotol® in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Urotol® (Urotol®) regulatory status in United States.

Marketing authorisation

FDA

Application: ANDA076953
Marketing authorisation holder: RANBAXY
Local brand name: TOLTERODINE
Indication: TABLET — ORAL
Status: approved

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Other Urology approved in United States

Frequently asked questions

Is Urotol® approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Urotol® in United States?

RANBAXY holds the US marketing authorisation.