Sold as Azmiro. Every FDA application for this active ingredient: 1 branded and 18 generic.
As of Nov 15, 2026, FDA lists 19 applications for Testosterone Cypionate (sold as Azmiro), first approved Jun 2, 2022, with 0 new uses approved and 0 published complete response letters.
| Testosterone Cypionate | Part D | $41.7M | +1% | 308,533 |
| Depo-Testosterone | Part B | $1.4M | +13% | 31,209 |
| Azmiro | Part D | $56K | New | 26 |
| Depo-Testosterone | Part D | $30K | -82% | 369 |
| AZMIRO | Part B | $6K | New | 29 |
| Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With HypogonadismMale Hypogonadism · Amneal Pharmaceuticals, LLC | Phase 3 | Recruiting | Oct 27, 2026 |
| Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · ECOG-ACRIN Cancer Research Group | Phase 2 / Phase 3 | Not yet recruiting | Oct 1, 2026 |
| Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI TrialSpinal Cord Injury, Spinal Cord Injuries · VA Office of Research and Development | Phase 2 / Phase 3 | Not yet recruiting | Aug 3, 2026 |
| Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited | Not applicable | Enrolling by invitation | May 6, 2026 |
| Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPCMetastatic Castration-resistant Prostate Cancer · H. Lee Moffitt Cancer Center and Research Institute | Phase 2 | Recruiting | Mar 17, 2026 |
| Ambulatory Blood Pressure Monitoring (ABPM) Study in Hypogonadal MenHypogonadism, Male · Azurity Pharmaceuticals | Phase 4 | Not yet recruiting | Jan 9, 2026 |
| Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active SurveillanceProstate Cancer, Hypogonadism, Male · University of Miami | Phase 4 | Recruiting | Dec 12, 2025 |
| Supraphysiologic Testosterone Priming Induces Darolutamide Extended ResponseMetastatic Castration-resistant Prostate Cancer · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 | Recruiting | Aug 26, 2025 |
| Jun 23, 1978 | Testosterone CypionateANDA 86029 | Watson Labs | 17 | Discontinued |
| Jul 25, 1979 | Depo-TestosteroneANDA 85635 | Pfizer | 18 | Marketed |
| Jul 30, 1981 | Testosterone CypionateANDA 86030 | Watson Pharms Inc | 22 | Discontinued |
| Jan 31, 2005 | Testosterone CypionateANDA 40530 | Padagis US | 7 | Marketed |
| Aug 10, 2006 | Testosterone CypionateANDA 40615 | Caplin One Labs | 4 | Discontinued |
| Dec 11, 2006 | Testosterone CypionateANDA 40652 | Rising | 5 | Discontinued |
| Jul 15, 2010 | Testosterone CypionateANDA 90387 | Hikma | 2 | Marketed |
| May 1, 2012 | Testosterone CypionateANDA 91244 | Hikma Farmaceutica | 8 | Marketed |
| Jun 3, 2013 | Testosterone CypionateANDA 201720 | Sun Pharm Inds Ltd | 8 | Discontinued |
| Jun 16, 2017 | Testosterone CypionateANDA 207742 | Am Regent | 3 | Marketed |
| Jun 19, 2018 | Testosterone CypionateANDA 210362 | Cipla | 2 | Marketed |
| Apr 24, 2019 | Testosterone CypionateANDA 206368 | Wilshire Pharms Inc | 1 | Marketed |
| Jun 2, 2022 | AzmiroNDA 216318 · New formulation or manufacturer | Azurity | 3 | Discontinued |
| Apr 13, 2023 | Testosterone CypionateANDA 215351 | Xiromed | 1 | Marketed |
| Oct 20, 2023 | Testosterone CypionateANDA 211817 | Eugia Pharma | 1 | Marketed |
| Sep 3, 2026 | Testosterone CypionateANDA 219478 | Bpi Labs | 0 | Marketed |
| — | Testosterone CypionateANDA 84401 | Watson Labs | 0 | Discontinued |
| — | Testosterone CypionateANDA 89326 | Quad Pharms | 0 | Discontinued |
| — | Testosterone CypionateANDA 89327 | Quad Pharms | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Pfizer
Hikma
Sun Pharm Inds Ltd
Cipla
Eugia Pharma