ANDA 76514, held by Chartwell Rx. Midodrine Hydrochloride.
As of Nov 15, 2026, ANDA 76514 (Midodrine Hydrochloride), held by Chartwell Rx, was first approved by FDA on Sep 11, 2003, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2003 | Original application | Approved |
| Midodrine Hydrochloride2.5MG · tablet;oral | Midodrine Hydrochloride | Discontinued |
| Midodrine Hydrochloride5MG · tablet;oral | Midodrine Hydrochloride | Discontinued |
| Midodrine Hydrochloride10MG · tablet;oral | Midodrine Hydrochloride | Discontinued |
| Dec 27, 2010 | Supplement 9Labeling | Approved | None posted |
| Jul 2, 2004 | Supplement 3 | Approved | |
| Jul 2, 2004 | Supplement 2Labeling | Approved | |
| Jul 2, 2004 | Supplement 1Manufacturing | Approved | |
| Sep 11, 2003 | Original application | 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
