Treats metastatic breast cancer. ANDA 74732, held by Mylan. Tamoxifen Citrate.
As of Nov 15, 2026, ANDA 74732 (Tamoxifen Citrate), held by Mylan, was first approved by FDA on Feb 20, 2003, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Metastatic Breast Cancer Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablet therapy. Adjuvant Treatment of Breast Cancer Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 20, 2003 | Original application | Approved |
| Tamoxifen CitrateEQ 20MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Tamoxifen CitrateEQ 10MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Jul 25, 2023 | Supplement 15Manufacturing | Approved | None posted |
| Feb 2, 2007 | Supplement 6Labeling | Approved | None posted |
| Mar 2, 2006 | Supplement 4Labeling | Approved | None posted |
| Feb 20, 2003 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
