Manages pain severe enough to require an opioid analgesic. ANDA 212024, held by Specgx LLC. Levorphanol Tartrate.
As of Nov 15, 2026, ANDA 212024 (Levorphanol Tartrate), held by Specgx LLC, was first approved by FDA on Dec 13, 2019, with 5 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 ( see WARNINGS ), reserve opioid analgesics, including Levorphanol Tartrate Tablets 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 |
|---|---|---|---|
| Dec 13, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levorphanol Tartrate2MG · tablet;oral | Levorphanol Tartrate | Rx |
| Jun 18, 2026 | Supplement 9REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 5REMS | Approved | None posted |
| Jun 7, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 4, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 13, 2019 | 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
