NDA 21048, held by Ortho Mcneil Pharm. Estradiol.
As of Nov 14, 2026, NDA 21048 (Estradiol), held by Ortho Mcneil Pharm, was first approved by FDA on Sep 20, 1999, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 1999 | Original applicationNew dosage form · Standard review | 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
