Sold as Entadfi. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Finasteride; Tadalafil (sold as Entadfi), first approved Dec 9, 2021, with 0 new uses approved and 0 published complete response letters.
| Dec 9, 2021 | EntadfiNDA 215423 ยท New combination | Blue Water Biotech | 0 | Discontinued |
| Mar 15, 2024 | Finasteride And TadalafilANDA 218232 | Zydus Lifesciences | 0 | Discontinued |
| Mar 19, 2025 | Finasteride And TadalafilANDA 218499 | Novitium Pharma | 0 | Marketed |
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
Zydus Lifesciences
Novitium Pharma