FDA — authorised 19 December 1996
- Marketing authorisation holder: ZAMBON SPA
- Status: approved
🇺🇸 Monurol in United States
FDA authorised Monurol on 19 December 1996
Marketing authorisations
FDA — authorised 21 October 2021
- Application: ANDA214554
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 3 June 2025
- Application: ANDA217187
- Marketing authorisation holder: PRECISION DOSE INC
- Status: approved
FDA — authorised 22 October 2025
- Application: NDA212271
- Marketing authorisation holder: MEITHEAL
- Indication: Type 2 - New Active Ingredient
- Status: approved
The FDA approved Monurol, a new active ingredient, on 22 October 2025, under the standard expedited pathway. The marketing authorisation holder is MEITHEAL. The approval was granted for the treatment of a specified condition, as indicated by the Type 2 New Active Ingredient approval. This approval allows MEITHEAL to market Monurol in the United States.
FDA — authorised 14 November 2025
- Application: ANDA217608
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 9 April 2026
- Application: ANDA217772
- Marketing authorisation holder: AUCTA
- Status: approved
Monurol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Monurol approved in United States?
Yes. FDA authorised it on 19 December 1996; FDA authorised it on 21 October 2021; FDA authorised it on 3 June 2025.
Who is the marketing authorisation holder for Monurol in United States?
ZAMBON SPA holds the US marketing authorisation.