FDA — authorised 18 February 1987
- Application: ANDA071293
- Marketing authorisation holder: SANDOZ
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ADS-8902 in United States
FDA authorised ADS-8902 on 18 February 1987
Marketing authorisations
FDA — authorised 30 October 1990
- Application: ANDA072655
- Marketing authorisation holder: G AND W LABS INC
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 October 1994
- Application: ANDA074170
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 July 1995
- Application: ANDA074509
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 27 October 1999
- Application: NDA021087
- Marketing authorisation holder: ROCHE
- Local brand name: TAMIFLU
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 September 2002
- Application: ANDA075819
- Marketing authorisation holder: ADAPTIS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 16 December 2002
- Application: ANDA076186
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2006
- Application: ANDA077659
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 December 2006
- Application: ANDA077992
- Marketing authorisation holder: PH HEALTH
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 May 2016
- Application: ANDA208278
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 2016
- Application: ANDA207570
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207571
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 June 2017
- Application: ANDA209047
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 June 2017
- Application: ANDA209035
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 June 2017
- Application: ANDA208966
- Marketing authorisation holder: ALEMBIC
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 February 2018
- Application: ANDA210403
- Marketing authorisation holder: JUBILANT GENERICS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 2018
- Application: NDA209410
- Marketing authorisation holder: SUPERNUS PHARMS
- Local brand name: OSMOLEX ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 March 2020
- Application: ANDA210129
- Marketing authorisation holder: RISING
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 May 2020
- Application: ANDA212044
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA211354
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 May 2022
- Application: ANDA212407
- Marketing authorisation holder: ADAPTIS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2024
- Application: ANDA214897
- Marketing authorisation holder: ZYDUS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA071382
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMANTADINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA071000
- Marketing authorisation holder: SOLVAY
- Local brand name: SYMADINE
- Indication: CAPSULE — ORAL
- Status: approved
Frequently asked questions
Is ADS-8902 approved in United States?
Yes. FDA authorised it on 18 February 1987; FDA authorised it on 30 October 1990; FDA authorised it on 28 October 1994.
Who is the marketing authorisation holder for ADS-8902 in United States?
SANDOZ holds the US marketing authorisation.