NDA 14006, held by Organon USA Inc. Ethylestrenol.
As of Nov 13, 2026, NDA 14006 (Maxibolin), held by Organon USA Inc, was first approved by FDA on Jan 7, 1965, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 1965 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Maxibolin2MG/5ML · elixir;oral | Ethylestrenol | Discontinued |
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
