NDA 20942, held by Roche. Midazolam Hydrochloride.
As of Nov 14, 2026, NDA 20942 (Versed), held by Roche, was first approved by FDA on Oct 15, 1998, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 1998 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VersedEQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · syrup;oral | Midazolam Hydrochloride | DiscontinuedReference drug |
| May 17, 2001 | Supplement 4Labeling · Priority review | Approved | None posted |
| Sep 25, 2000 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jun 30, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Nov 24, 1999 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Oct 15, 1998 | Original applicationNew dosage form · Priority 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
