Active ingredient
Toremifene
3 finished FDA listings contain Toremifene as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TOREMIFENE CITRATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 60 mg/1
- Brand names in FDA listings
- Fareston
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 38409
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020497 | KYOWA KIRIN | 1997-05-29 | 1 |
| ANDA 208813 | RISING | 2018-12-04 | 1 |
| ANDA 212818 | MSN | 2020-08-18 | 1 |
Official labeling on DailyMed
- TOREMIFENE CITRATE TABLET [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2025-09-25
- TOREMIFENE CITRATE TABLET [RISING PHARMA HOLDINGS, INC.] · version 4 · 2025-07-18
- FARESTON (TOREMIFENE CITRATE) TABLET [KYOWA KIRIN, INC.] · version 11 · 2024-11-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.