FDA — authorised 8 October 2008
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
🇺🇸 Rapaflo in United States
FDA authorised Rapaflo on 8 October 2008
Marketing authorisations
FDA — authorised 8 October 2008
- Application: NDA022206
- Marketing authorisation holder: ABBVIE
- Local brand name: RAPAFLO
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 March 2017
- Application: ANDA204726
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 December 2018
- Application: ANDA211166
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 3 December 2018
- Application: ANDA209745
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 December 2018
- Application: ANDA210687
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 3 December 2018
- Application: ANDA211060
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 2018
- Application: ANDA210626
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 22 November 2019
- Application: ANDA211731
- Marketing authorisation holder: ALEMBIC
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 February 2020
- Application: ANDA204793
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 July 2021
- Application: ANDA206541
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 3 January 2022
- Application: ANDA213230
- Marketing authorisation holder: CREEKWOOD PHARMS
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 January 2022
- Application: ANDA209029
- Marketing authorisation holder: PRINSTON INC
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 December 2022
- Application: ANDA204816
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 February 2025
- Application: ANDA210396
- Marketing authorisation holder: TORRENT
- Local brand name: SILODOSIN
- Indication: CAPSULE — ORAL
- Status: approved
Rapaflo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Rapaflo approved in United States?
Yes. FDA authorised it on 8 October 2008; FDA authorised it on 8 October 2008; FDA authorised it on 31 March 2017.
Who is the marketing authorisation holder for Rapaflo in United States?
ACTAVIS LABS UT INC holds the US marketing authorisation.