Treats postmenopausal women with hormone receptor-positive … metastatic breast cancer. ANDA 78058, held by Teva Pharms. Anastrozole.
As of Nov 15, 2026, ANDA 78058 (Anastrozole), held by Teva Pharms, was first approved by FDA on Jun 28, 2010, with 7 approved supplements and 0 published complete response letters.
Anastrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Anastrozole1MG · tablet;oral | Anastrozole | Rx |
| Nov 9, 2026 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 17, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 28, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jul 23, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 23, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 8, 2013 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 22, 2011 | Supplement 4Labeling | Approved | None posted |
| Jun 28, 2010 | 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
