FDA — authorised 3 December 1973
- Application: ANDA080742
- Marketing authorisation holder: BEL MAR
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 TESTOSTERONE PROPIONATE in United States
FDA authorised TESTOSTERONE PROPIONATE on 3 December 1973 · 133 US adverse-event reports
Marketing authorisations
FDA — authorised 3 December 1973
- Application: ANDA080741
- Marketing authorisation holder: BEL MAR
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 December 1973
- Application: ANDA080743
- Marketing authorisation holder: BEL MAR
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 May 1974
- Application: ANDA080188
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA085490
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA080254
- Marketing authorisation holder: LILLY
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080276
- Marketing authorisation holder: ELKINS SINN
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089283
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA083595
- Marketing authorisation holder: WATSON LABS
- Local brand name: TESTOSTERONE PROPIONATE
- Indication: INJECTABLE — INJECTION
- 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: 133
Most-reported reactions
- Drug Abuse — 40 reports (30.08%)
- Renal Tubular Acidosis — 12 reports (9.02%)
- Dyspnoea — 11 reports (8.27%)
- Nausea — 11 reports (8.27%)
- Tubulointerstitial Nephritis — 11 reports (8.27%)
- Off Label Use — 10 reports (7.52%)
- Product Use In Unapproved Indication — 10 reports (7.52%)
- Vomiting — 10 reports (7.52%)
- Anxiety — 9 reports (6.77%)
- Intentional Product Misuse — 9 reports (6.77%)
TESTOSTERONE PROPIONATE 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 PROPIONATE approved in United States?
Yes. FDA authorised it on 3 December 1973; FDA authorised it on 3 December 1973; FDA authorised it on 3 December 1973.
Who is the marketing authorisation holder for TESTOSTERONE PROPIONATE in United States?
BEL MAR holds the US marketing authorisation.