Active ingredient
Tamoxifen
18 finished FDA listings contain Tamoxifen as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TAMOXIFEN CITRATE
- Dosage forms
- Liquid, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 11
- Strengths listed
- 10 mg/1 · 20 mg/1 · 20 mg/10ml
- Brand names in FDA listings
- Soltamox
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10324
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 |
|---|---|---|---|
| ANDA 070929 | ACTAVIS LABS FL INC | 2003-02-20 | 7 |
| ANDA 075797 | DR REDDYS LABS SA | 2003-02-20 | 3 |
| ANDA 074732 | MYLAN | 2003-02-20 | 2 |
| NDA 021807 | MAYNE PHARMA COMMRCL | 2005-10-29 | 1 |
| ANDA 213358 | EUGIA PHARMA | 2020-08-14 | 5 |
Official labeling on DailyMed
- TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.] · version 14 · 2026-08-20
- TAMOXIFEN CITRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] · version 2 · 2026-05-04
- TAMOXIFEN CITRATE TABLET [A-S MEDICATION SOLUTIONS] · version 13 · 2026-03-20
- TAMOXIFEN CITRATE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-03-20
- TAMOXIFEN CITRATE TABLET [ACTAVIS PHARMA, INC.] · version 8 · 2025-12-19
- TAMOXIFEN CITRATE TABLET, FILM COATED [MAYNE PHARMA COMMERCIAL LLC] · version 5 · 2025-11-17
- TAMOXIFEN CITRATE TABLET [A-S MEDICATION SOLUTIONS] · version 16 · 2025-11-17
- TAMOXIFEN CITRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2024-11-11
- TAMOXIFEN CITRATE TABLET, FILM COATED [DR. REDDY'S LABRATORIES INC.] · version 1 · 2024-08-23
- TAMOXIFEN CITRATE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 3 · 2024-07-19
- TAMOXIFEN CITRATE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2024-01-22
- TAMOXIFEN CITRATE TABLET [PROFICIENT RX LP] · version 5 · 2022-09-12
Showing the 12 most recent of 14 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.