Treats metastatic breast cancer in postmenopausal women with estrogen-receptor positive…. ANDA 212818, held by Msn. Toremifene Citrate.
As of Nov 14, 2026, ANDA 212818 (Toremifene Citrate), held by Msn, was first approved by FDA on Aug 18, 2020, with 0 approved supplements and 0 published complete response letters.
Toremifene citrate tablets are estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Toremifene CitrateEQ 60MG BASE · tablet;oral | Toremifene 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
