FDA — authorised 14 August 1973
- Application: NDA017398
- Marketing authorisation holder: SANDOZ
- Local brand name: REGONOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Pyridostigmine, Tacrolimus in United States
FDA authorised Pyridostigmine, Tacrolimus on 14 August 1973
Marketing authorisations
FDA — authorised 27 November 1990
- Application: ANDA089572
- Marketing authorisation holder: SOLVAY
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 December 2002
- Application: ANDA040457
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2003
- Application: NDA020414
- Marketing authorisation holder: US ARMY
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2003
- Application: ANDA040502
- Marketing authorisation holder: IMPAX LABS
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 October 2003
- Application: ANDA040512
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 June 2015
- Application: ANDA205650
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2015
- Application: ANDA204737
- Marketing authorisation holder: ALVOGEN
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 September 2015
- Application: ANDA203184
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA211181
- Marketing authorisation holder: MLV
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2019
- Application: ANDA211694
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 9 January 2020
- Application: ANDA208797
- Marketing authorisation holder: RISING
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 10 January 2020
- Application: ANDA212702
- Marketing authorisation holder: AMNEAL
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 19 April 2022
- Application: ANDA212405
- Marketing authorisation holder: MILLA PHARMS
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 September 2023
- Application: ANDA216512
- Marketing authorisation holder: MSN
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 4 October 2024
- Application: NDA217604
- Marketing authorisation holder: AMNEAL
- Local brand name: PYRIDOSTIGMINE BROMIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Frequently asked questions
Is Pyridostigmine, Tacrolimus approved in United States?
Yes. FDA authorised it on 14 August 1973; FDA authorised it on 27 November 1990; FDA authorised it on 26 December 2002.
Who is the marketing authorisation holder for Pyridostigmine, Tacrolimus in United States?
SANDOZ holds the US marketing authorisation.