Treats transient insomnia characterized. NDA 215721, held by Almatica. Zolpidem Tartrate.
As of Nov 13, 2026, NDA 215721 (Zolpidem Tartrate), held by Almatica, was first approved by FDA on May 9, 2023, with 0 approved supplements and 1 published complete response letter.
Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 13, 2023 | Zolpidem tartrateProduct Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zolpidem Tartrate7.5MG · capsule;oral | Zolpidem Tartrate | RxReference drug |
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
