ANDA 216422, held by Galenicum Hlth. Diazepam.
As of Nov 14, 2026, ANDA 216422 (Diazepam), held by Galenicum Hlth, was first approved by FDA on May 19, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam50MG/10ML (5MG/ML) ยท injectable;injection | Diazepam | 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
