FDA — authorised 27 July 1961
- Marketing authorisation holder: MERCK
- Status: approved
🇺🇸 Colcrys in United States
FDA authorised Colcrys on 27 July 1961
Marketing authorisations
FDA — authorised 27 July 1961
- Application: NDA012383
- Marketing authorisation holder: MERCK
- Local brand name: COLBENEMID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 1977
- Application: ANDA085552
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROBEN-C
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 February 1984
- Application: ANDA084279
- Marketing authorisation holder: WATSON LABS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 13 May 2008
- Application: ANDA040618
- Marketing authorisation holder: NOVAST LABS
- Local brand name: PROBENECID AND COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 July 2011
- Application: NDA022352
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: REMS
- Status: approved
FDA — authorised 28 September 2016
- Application: ANDA204711
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2018
- Application: ANDA208678
- Marketing authorisation holder: PH HEALTH
- Local brand name: COLCHICINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 February 2019
- Application: ANDA211519
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 July 2019
- Application: ANDA204461
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2019
- Application: ANDA209470
- Marketing authorisation holder: MYLAN
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
Mylan received marketing authorization from the FDA for Colcrys on May 29, 2024. The approval was granted under the standard expedited pathway. Colcrys is a medication used for its labeling-approved indication.
FDA — authorised 5 February 2020
- Application: ANDA210425
- Marketing authorisation holder: GRANULES
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 2021
- Application: ANDA208993
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2022
- Application: ANDA209173
- Marketing authorisation holder: STRIDES PHARMA
- Status: approved
FDA — authorised 24 October 2023
- Application: ANDA217030
- Marketing authorisation holder: RISING
- Local brand name: PROBENECID AND COLCHICINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA210757
- Marketing authorisation holder: GRANULES
- Local brand name: COLCHICINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 February 2026
- Application: ANDA212880
- Marketing authorisation holder: MICRO LABS
- Local brand name: COLCHICINE
- Indication: CAPSULE — ORAL
- Status: approved
Colcrys 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 Colcrys approved in United States?
Yes. FDA authorised it on 27 July 1961; FDA authorised it on 27 July 1961; FDA authorised it on 15 September 1977.
Who is the marketing authorisation holder for Colcrys in United States?
MERCK holds the US marketing authorisation.