ANDA 219320, held by Padagis Israel Pharma Ltd. Diazepam.
As of Nov 13, 2026, ANDA 219320 (Diazepam), held by Padagis Israel Pharma Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2025 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam10MG/1SPRAY ยท spray | Diazepam | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters