Treats symptomatic orthostatic hypotension (OH). ANDA 212543, held by Rubicon Research. Midodrine Hydrochloride.
As of Nov 15, 2026, ANDA 212543 (Midodrine Hydrochloride), held by Rubicon Research, was first approved by FDA on Aug 19, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Midodrine Hydrochloride Tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because Midodrine Hydrochloride Tablets, USP 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, USP 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 |
|---|---|---|---|
| Aug 19, 2019 | Original application | Approved | None posted |
| Midodrine Hydrochloride2.5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Midodrine Hydrochloride5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Midodrine Hydrochloride10MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Nov 20, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Original application | Approved | None posted |
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
