Treats metastatic breast cancer. ANDA 70929, held by Actavis Labs Fl Inc. Tamoxifen Citrate.
As of Nov 15, 2026, ANDA 70929 (Tamoxifen Citrate), held by Actavis Labs Fl Inc, was first approved by FDA on Feb 20, 2003, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Metastatic Breast Cancer: Tamoxifen citrate tablets, USP 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, USP 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 | None posted |
| Tamoxifen CitrateEQ 10MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Tamoxifen CitrateEQ 20MG BASE · tablet;oral | Tamoxifen Citrate | Rx |
| Jan 25, 2007 | Supplement 5Labeling | Approved | None posted |
| Feb 20, 2003 | Original application | Approved | None posted |
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
