Levorphanol Tartrate

Manages pain severe enough to require an opioid analgesic. ANDA 74278, held by Hikma. Levorphanol Tartrate.

As of Nov 15, 2026, ANDA 74278 (Levorphanol Tartrate), held by Hikma, was first approved by FDA on Mar 31, 2000, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2000
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Mar 31, 2000	Original application	Approved	REMS Review Letter

Products

3 strengths and forms


Levorphanol Tartrate2MG · tablet;oral	Levorphanol Tartrate	Rx
Levorphanol Tartrate1MG · tablet;oral	Levorphanol Tartrate	Discontinued
Levorphanol Tartrate3MG · tablet;oral	Levorphanol Tartrate	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 27REMS	Approved	None posted
Dec 22, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 22REMS	Approved	None posted
Dec 15, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Mar 5, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 21, 2018	Supplement 13Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 12REMS	Approved	None posted
Jun 18, 2018	Supplement 11	Approved	Letter
Dec 16, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Jul 16, 2008	Supplement 5Labeling	Approved	None posted
Apr 8, 2005	Supplement 3Labeling	Approved	None posted
Sep 5, 2000	Supplement 1Manufacturing	Approved	None posted
Mar 31, 2000	Original application	Approved	REMS Review Letter

Identifiers

Application: ANDA 74278
Drugs@FDA: Overview at FDA
Company: Hikma

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