ANDA 40326, held by Pharmobedient. Estradiol.
As of Nov 14, 2026, ANDA 40326 (Estradiol), held by Pharmobedient, was first approved by FDA on Apr 21, 1999, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 1999 | Original application | Approved |
| Feb 15, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Jan 4, 2019 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 14, 2009 | Supplement 8Labeling | Approved | None posted |
| Jan 16, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Nov 29, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Apr 21, 1999 | 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
