Levorphanol Tartrate

Manages pain severe enough to require an opioid analgesic. ANDA 211484, held by Acertis Pharms. Levorphanol Tartrate.

As of Nov 15, 2026, ANDA 211484 (Levorphanol Tartrate), held by Acertis Pharms, was first approved by FDA on Dec 13, 2018, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 13, 2018
Review: Standard
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Dec 13, 2018	Original application	Approved	REMS Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levorphanol Tartrate2MG · tablet;oral	Levorphanol Tartrate	Rx

All 9 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 13REMS	Approved	None posted
Dec 22, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Dec 22, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 11REMS	Approved	None posted
Dec 15, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Mar 1, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 13, 2018	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 211484
Drugs@FDA: Overview at FDA
Company: Acertis Pharmaceuticals

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