FDA — authorised 13 July 1972
- Marketing authorisation holder: ACTIENT PHARMS
- Status: approved
🇺🇸 Androgel in United States
FDA authorised Androgel on 13 July 1972
Marketing authorisations
FDA — authorised 10 May 1983
- Application: ANDA086420
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
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 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 23 October 2017
- Application: ANDA208061
- Marketing authorisation holder: LUPIN LTD
- 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 23 September 2019
- Application: ANDA209390
- Marketing authorisation holder: TWI PHARMS
- Local brand name: TESTOSTERONE
- Indication: GEL, METERED — TRANSDERMAL
- Status: approved
FDA — authorised 19 November 2019
- Application: NDA209863
- Marketing authorisation holder: ANTARES PHARMA INC
- Indication: Labeling
- Status: approved
FDA — authorised 16 April 2020
- Application: ANDA210835
- Marketing authorisation holder: XIROMED
- 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 15 July 2025
- Application: ANDA205328
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Indication: Labeling
- Status: approved
The FDA approved Androgel for labeling indications on July 15, 2025. This approval was granted to ACTAVIS LABS UT INC under application number ANDA205328. The approval was processed through the standard expedited pathway.
FDA — authorised 12 September 2025
- Application: NDA206089
- Marketing authorisation holder: TOLMAR
- Indication: Labeling
- Status: approved
The FDA approved Androgel for labeling indications on September 12, 2025. This approval was granted to TOLMAR under the standard expedited pathway. The application number for this approval is NDA206089.
Androgel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Androgel approved in United States?
Yes. FDA authorised it on 13 July 1972; FDA authorised it on 10 May 1983; FDA authorised it on 7 July 1983.
Who is the marketing authorisation holder for Androgel in United States?
ACTIENT PHARMS holds the US marketing authorisation.