ANDA 40312, held by Novo Nordisk Inc. Estradiol.
As of Nov 14, 2026, ANDA 40312 (Innofem), held by Novo Nordisk Inc, was first approved by FDA on Nov 19, 1999, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 1999 | Original application | Approved |
| Jul 15, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Jan 17, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Nov 19, 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
