Treats symptomatic orthostatic hypotension (OH). ANDA 76577, held by Mylan Pharms Inc. Midodrine Hydrochloride.
As of Nov 15, 2026, ANDA 76577 (Midodrine Hydrochloride), held by Mylan Pharms Inc, was first approved by FDA on Sep 10, 2003, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets' effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2003 | Original application | Approved |
| Midodrine Hydrochloride2.5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Midodrine Hydrochloride5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Midodrine Hydrochloride10MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Nov 4, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 26, 2004 | Supplement 1Labeling | Approved | None posted |
| Sep 10, 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
