Manages pain severe enough to require an opioid analgesic. ANDA 213479, held by Novitium Pharma. Levorphanol Tartrate.
As of Nov 15, 2026, ANDA 213479 (Levorphanol Tartrate), held by Novitium Pharma, was first approved by FDA on Jul 1, 2020, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, includinglevorphanol, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2020 | Original application | Approved |
| Levorphanol Tartrate2MG · tablet;oral | Levorphanol Tartrate | Rx |
| Levorphanol Tartrate3MG · tablet;oral | Levorphanol Tartrate | Rx |
| Levorphanol Tartrate1MG · tablet;oral | Levorphanol Tartrate | Rx |
| Jun 18, 2026 | Supplement 28REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 26Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 17REMS | Approved | None posted |
| Jun 12, 2024 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jul 1, 2020 | Original application | Approved |
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
