FDA — authorised 31 December 1987
- Application: NDA019594
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: ACTIGALL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Actigall in United States
FDA authorised Actigall on 31 December 1987
Marketing authorisations
FDA — authorised 31 December 1987
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Status: approved
FDA — authorised 14 March 2000
- Application: ANDA075517
- Marketing authorisation holder: EPIC PHARMA
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 May 2000
- Application: ANDA075592
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 May 2009
- Application: ANDA079184
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 2010
- Application: ANDA090530
- Marketing authorisation holder: QUAGEN
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 July 2011
- Application: ANDA090801
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 2011
- Application: ANDA200826
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2013
- Application: ANDA202540
- Marketing authorisation holder: PH HEALTH
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2018
- Application: ANDA210707
- Marketing authorisation holder: ABHAI LLC
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 October 2018
- Application: ANDA211145
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA212452
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 February 2020
- Application: ANDA213200
- Marketing authorisation holder: RISING
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA205789
- Marketing authorisation holder: LGM PHARMA
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 August 2020
- Application: ANDA213555
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 August 2020
- Application: ANDA213504
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA210344
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 July 2021
- Application: ANDA214329
- Marketing authorisation holder: RK PHARMA
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 November 2022
- Application: ANDA214849
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: URSODIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 August 2024
- Application: ANDA214717
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: URSODIOL
- Indication: TABLET — ORAL
- Status: approved
Actigall 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 Actigall approved in United States?
Yes. FDA authorised it on 31 December 1987; FDA authorised it on 31 December 1987; FDA authorised it on 14 March 2000.
Who is the marketing authorisation holder for Actigall in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.