Treats insomnia. ANDA 90374, held by Orbion Pharms. Zaleplon.
As of Nov 14, 2026, ANDA 90374 (Zaleplon), held by Orbion Pharms, was first approved by FDA on Sep 17, 2009, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2009 | Original application | Approved | None posted |
| Oct 21, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 21, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 11, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 17, 2009 | 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
