FDA — authorised 8 April 1994
- Application: NDA050709
- Marketing authorisation holder: ASTELLAS
- Local brand name: PROGRAF
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Prograf in United States
FDA authorised Prograf on 8 April 1994
Marketing authorisations
FDA — authorised 8 April 1994
- Marketing authorisation holder: ASTELLAS
- Status: approved
FDA — authorised 8 April 1994
- Application: NDA050708
- Marketing authorisation holder: ASTELLAS
- Local brand name: PROGRAF
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 June 2002
- Application: NDA050777
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 12 May 2010
- Application: ANDA090509
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 September 2010
- Application: ANDA090596
- Marketing authorisation holder: MYLAN
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 2011
- Application: ANDA091195
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA090802
- Marketing authorisation holder: PANACEA
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 July 2014
- Application: ANDA090687
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 September 2014
- Application: ANDA200744
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: TACROLIMUS
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 April 2018
- Application: ANDA210393
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TACROLIMUS
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 May 2018
- Application: NDA210115
- Marketing authorisation holder: ASTELLAS
- Local brand name: PROGRAF
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 January 2019
- Application: ANDA211688
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TACROLIMUS
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 November 2020
- Application: ANDA213112
- Marketing authorisation holder: CONCORD BIOTECH LTD
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 November 2020
- Application: ANDA212297
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 November 2020
- Application: ANDA206662
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 November 2020
- Application: ANDA203740
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TACROLIMUS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 May 2023
- Application: ANDA065461
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 14 September 2023
- Application: NDA204096
- Marketing authorisation holder: ASTELLAS
- Indication: Labeling
- Status: approved
FDA — authorised 10 October 2023
- Application: ANDA212387
- Marketing authorisation holder: ENCUBE
- Local brand name: TACROLIMUS
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 25 January 2024
- Application: ANDA215012
- Marketing authorisation holder: CHENGDU
- Local brand name: TACROLIMUS
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 February 2025
- Application: ANDA217108
- Marketing authorisation holder: NEXUS
- Local brand name: TACROLIMUS
- Indication: INJECTABLE — INJECTION
- Status: approved
Prograf 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 Prograf approved in United States?
Yes. FDA authorised it on 8 April 1994; FDA authorised it on 8 April 1994; FDA authorised it on 8 April 1994.
Who is the marketing authorisation holder for Prograf in United States?
ASTELLAS holds the US marketing authorisation.