FDA — authorised 10 December 1980
- Application: ANDA085598
- Marketing authorisation holder: WATSON PHARMS INC
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TESTOSTERONE ENANTHATE in United States
FDA authorised TESTOSTERONE ENANTHATE on 10 December 1980 · 304 US adverse-event reports
Marketing authorisations
FDA — authorised 14 June 2006
- Application: ANDA040575
- Marketing authorisation holder: NEXUS
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 October 2009
- Application: ANDA040647
- Marketing authorisation holder: RISING
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 September 2012
- Application: ANDA091120
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2024
- Application: ANDA212659
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA
- Application: ANDA083667
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085599
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089324
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA089325
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: TESTOSTERONE ENANTHATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 304
Most-reported reactions
- Drug Ineffective — 58 reports (19.08%)
- Fatigue — 34 reports (11.18%)
- Off Label Use — 33 reports (10.86%)
- Drug Abuse — 32 reports (10.53%)
- Cerebrovascular Accident — 26 reports (8.55%)
- Myocardial Infarction — 26 reports (8.55%)
- Atrial Fibrillation — 25 reports (8.22%)
- Product Use In Unapproved Indication — 25 reports (8.22%)
- Deep Vein Thrombosis — 23 reports (7.57%)
- Nausea — 22 reports (7.24%)
TESTOSTERONE ENANTHATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TESTOSTERONE ENANTHATE approved in United States?
Yes. FDA authorised it on 10 December 1980; FDA authorised it on 14 June 2006; FDA authorised it on 5 October 2009.
Who is the marketing authorisation holder for TESTOSTERONE ENANTHATE in United States?
WATSON PHARMS INC holds the US marketing authorisation.