Codeine Sulfate

Manages mild to moderate pain. NDA 22402, held by Hikma. Codeine Sulfate.

As of Nov 14, 2026, NDA 22402 (Codeine Sulfate), held by Hikma, was first approved by FDA on Jul 16, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2009
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 Codeine Sulfate 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 14 submissions below

Date	Submission	Status	Documents
Jul 16, 2009	Original applicationTYPE 7 · Standard review	Approved	REMS Summary Review Review Label

Products

3 strengths and forms


Codeine Sulfate15MG · tablet;oral	Codeine Sulfate	RxReference drug
Codeine Sulfate30MG · tablet;oral	Codeine Sulfate	RxReference drug
Codeine Sulfate60MG · tablet;oral	Codeine Sulfate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 19REMS	Approved	Letter
Dec 22, 2025	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 16REMS	Approved	Letter
Dec 15, 2023	Supplement 15Labeling · Standard review	Approved	Medication Guide Letter Label
Mar 4, 2021	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 7, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 18, 2018	Supplement 10REMS	Approved	Letter Label
Sep 18, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 29, 2017	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 8Labeling · Standard review	Approved	Label Letter
Jun 17, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
May 9, 2013	Supplement 6Labeling	Approved	Letter Label
Apr 17, 2012	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 16, 2009	Original applicationTYPE 7 · Standard review	Approved	REMS Summary Review Review Label

Identifiers

Application: NDA 22402
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