NDA 21396, held by Wyeth Ayerst. Conjugated Estrogens/Medroxyprogesterone Acetate.
As of Nov 14, 2026, NDA 21396 (Prempro/Premphase), held by Wyeth Ayerst, was first approved by FDA on Jun 4, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2003 | Original applicationNew indication · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prempro/Premphase0.45MG/1.5MG & 0.3MG/1.5MG · tablet; oral | Conjugated Estrogens/Medroxyprogesterone Acetate | Rx |
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
