NDA 201110, held by Ferring Pharms Inc. Progesterone.
As of Nov 13, 2026, NDA 201110 (Milprosa), held by Ferring Pharms Inc, was first approved by FDA on Apr 29, 2020, with 0 approved supplements and 2 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 23, 2016 | ProgesteroneDevice, Clinical | Approved |
| Feb 28, 2011 | ProgesteroneProduct Quality, Clinical, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Milprosa1.78GM · system;vaginal | Progesterone | DiscontinuedReference drug |
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
