FDA — authorised 23 June 1978
- Application: ANDA086029
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Testosterone Cypionate in United States
FDA authorised Testosterone Cypionate on 23 June 1978
Marketing authorisations
FDA — authorised 25 July 1979
- Application: ANDA085635
- Marketing authorisation holder: PFIZER
- Local brand name: DEPO-TESTOSTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 1981
- Application: ANDA086030
- Marketing authorisation holder: WATSON PHARMS INC
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 2005
- Application: ANDA040530
- Marketing authorisation holder: PADAGIS US
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 August 2006
- Application: ANDA040615
- Marketing authorisation holder: CAPLIN ONE LABS
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 December 2006
- Application: ANDA040652
- Marketing authorisation holder: RISING
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 May 2012
- Application: ANDA091244
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 June 2013
- Application: ANDA201720
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2017
- Application: ANDA207742
- Marketing authorisation holder: AM REGENT
- Status: approved
FDA — authorised 19 June 2018
- Application: ANDA210362
- Marketing authorisation holder: CIPLA
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA206368
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 June 2022
- Application: NDA216318
- Marketing authorisation holder: AZURITY
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 13 April 2023
- Application: ANDA215351
- Marketing authorisation holder: XIROMED
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 October 2023
- Application: ANDA211817
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089327
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089326
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: TESTOSTERONE CYPIONATE
- Indication: Injectable — Injection
- Status: approved
Testosterone Cypionate 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 Testosterone Cypionate approved in United States?
Yes. FDA authorised it on 23 June 1978; FDA authorised it on 25 July 1979; FDA authorised it on 30 July 1981.
Who is the marketing authorisation holder for Testosterone Cypionate in United States?
WATSON LABS holds the US marketing authorisation.