Treats metastatic breast cancer. ANDA 213358, held by Eugia Pharma. Tamoxifen Citrate.
As of Nov 15, 2026, ANDA 213358 (Tamoxifen Citrate), held by Eugia Pharma, was first approved by FDA on Aug 14, 2020, with 0 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 tablets therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2020 | Original application | Approved | None posted |
| Tamoxifen CitrateEQ 10MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Tamoxifen CitrateEQ 20MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
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
