Treats symptomatic orthostatic hypotension (OH). ANDA 76725, held by Beijing Yiling. Midodrine Hydrochloride.
As of Nov 15, 2026, ANDA 76725 (Orvaten), held by Beijing Yiling, was first approved by FDA on Nov 3, 2004, 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's 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 |
|---|---|---|---|
| Nov 3, 2004 | Original application | Approved | None posted |
| Orvaten2.5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Orvaten5MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Orvaten10MG · tablet;oral | Midodrine Hydrochloride | Rx |
| Nov 13, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| May 5, 2005 | Supplement 3Labeling | Approved | None posted |
| Nov 3, 2004 | 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
