FDA — authorised 10 May 1983
- Application: ANDA086420
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TSX-002 in United States
FDA authorised TSX-002 on 10 May 1983
Marketing authorisations
FDA — authorised 7 July 1983
- Application: ANDA086417
- Marketing authorisation holder: DR REDDYS
- Local brand name: TESTOSTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 August 1983
- Application: ANDA086419
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 1997
- Application: NDA020791
- Marketing authorisation holder: ALZA
- Local brand name: TESTODERM TTS
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 19 June 2003
- Application: NDA021543
- Marketing authorisation holder: AUXILIUM PHARMS LLC
- Local brand name: STRIANT
- Indication: TABLET, EXTENDED RELEASE — BUCCAL
- Status: approved
FDA — authorised 27 January 2006
- Application: ANDA076737
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: TESTOSTERONE
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 23 May 2007
- Application: ANDA076744
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: TESTOSTERONE
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 5 August 2015
- Application: ANDA204571
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA204255
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 12 July 2017
- Application: ANDA205781
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TESTOSTERONE
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 7 August 2017
- Application: ANDA205328
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 23 October 2017
- Application: ANDA208061
- Marketing authorisation holder: LUPIN
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 29 January 2018
- Application: ANDA209533
- Marketing authorisation holder: CIPLA
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA208620
- Marketing authorisation holder: ENCUBE
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA208560
- Marketing authorisation holder: LUPIN
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA204570
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: TESTOSTERONE
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA — authorised 23 September 2019
- Application: ANDA209390
- Marketing authorisation holder: TWI PHARMS
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 16 April 2020
- Application: ANDA210835
- Marketing authorisation holder: XIROMED
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 25 November 2020
- Application: ANDA209181
- Marketing authorisation holder: APOTEX
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 11 January 2021
- Application: ANDA212301
- Marketing authorisation holder: ENCUBE
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 3 March 2021
- Application: ANDA213922
- Marketing authorisation holder: ALEMBIC
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 14 June 2021
- Application: ANDA212882
- Marketing authorisation holder: ALEMBIC
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 3 September 2021
- Application: ANDA209836
- Marketing authorisation holder: TWI PHARMS
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA212984
- Marketing authorisation holder: ENCUBE
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA
- Application: ANDA207337
- Marketing authorisation holder: SANDOZ INC
- Local brand name: TESTOSTERONE
- Indication: SOLUTION, METERED — TRANSDERMAL
- Status: approved
Frequently asked questions
Is TSX-002 approved in United States?
Yes. FDA authorised it on 10 May 1983; FDA authorised it on 7 July 1983; FDA authorised it on 23 August 1983.
Who is the marketing authorisation holder for TSX-002 in United States?
WATSON LABS holds the US marketing authorisation.