ANDA 217178, held by Long Grove Pharms. Diazepam.
As of Nov 13, 2026, ANDA 217178 (Diazepam), held by Long Grove Pharms, was first approved by FDA on Dec 31, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 31, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam10MG/2ML (5MG/ML) ยท injectable;injection | Diazepam | Rx |
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
