ANDA 210488, held by Teva Pharms USA. Estradiol.
As of Nov 14, 2026, ANDA 210488 (Estradiol), held by Teva Pharms USA, was first approved by FDA on Mar 30, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estradiol0.01% · cream;vaginal | Estradiol | Rx |
| Feb 15, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 9, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 30, 2018 | 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
