Treats status epilepticus. ANDA 217598, held by Fresenius Kabi USA. Lorazepam.
As of Nov 13, 2026, ANDA 217598 (Lorazepam), held by Fresenius Kabi USA, was first approved by FDA on Nov 18, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Status Epilepticus Lorazepam Injection is indicated for the treatment of status epilepticus. Preanesthetic Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see PRECAUTIONS, Information for Patients ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lorazepam2MG/ML · injectable;injection | Lorazepam | 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
