Treats metastatic breast cancer. ANDA 75797, held by Dr Reddys Labs SA. Tamoxifen Citrate.
As of Nov 15, 2026, ANDA 75797 (Tamoxifen Citrate), held by Dr Reddys Labs SA, 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 is 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 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 |
|---|---|---|---|
| Feb 20, 2003 | Original application | Approved |
| Tamoxifen CitrateEQ 10MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Tamoxifen CitrateEQ 20MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Dec 1, 2006 | Supplement 4Labeling | Approved | None posted |
| Aug 18, 2005 | Supplement 3Labeling | Approved | None posted |
| Apr 20, 2005 | Supplement 2Labeling | 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
