Treats symptomatic orthostatic hypotension (OH). ANDA 207169, held by Ph Health. Midodrine Hydrochloride.
As of Nov 15, 2026, ANDA 207169 (Midodrine Hydrochloride), held by Ph Health, was first approved by FDA on Oct 29, 2018, with 0 approved supplements 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 |
|---|---|---|---|
| Oct 29, 2018 | 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 |
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
