Manages pain severe enough to require an opioid analgesic. ANDA 213906, held by Sun Pharm Inds Inc. Levorphanol Tartrate.
As of Nov 15, 2026, ANDA 213906 (Levorphanol Tartrate), held by Sun Pharm Inds Inc, was first approved by FDA on Jun 17, 2021, 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, 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 |
|---|---|---|---|
| Jun 17, 2021 | Original application | Approved | None posted |
| Levorphanol Tartrate2MG · tablet;oral | Levorphanol Tartrate | Rx |
| Levorphanol Tartrate3MG · tablet;oral | Levorphanol Tartrate | Rx |
| Jun 18, 2026 | Supplement 8REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 4REMS | Approved | None posted |
| Jun 7, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 17, 2021 | Original application | Approved | None posted |
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
