Treats metastatic breast cancer in postmenopausal women with estrogen-receptor positive…. ANDA 208813, held by Rising. Toremifene Citrate.
As of Nov 14, 2026, ANDA 208813 (Toremifene Citrate), held by Rising, was first approved by FDA on Dec 4, 2018, with 1 approved supplement and 0 published complete response letters.
Toremifene citrate tablets are an 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 |
|---|---|---|---|
| Dec 4, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Toremifene CitrateEQ 60MG BASE · tablet;oral | Toremifene Citrate | Rx |
| Jan 14, 2026 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 4, 2018 | 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
