Meperidine Hydrochloride

Manages acute pain severe enough to require an opioid analgesic. ANDA 88744, held by Hikma. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 88744 (Meperidine Hydrochloride), held by Hikma, was first approved by FDA on Jan 30, 1985, with 28 approved supplements and 0 published complete response letters.

First approved: Jan 30, 1985
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meperidine Hydrochloride Tablets and Oral Solution are indicated for the management of acute 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 Meperidine Hydrochloride Tablets or Oral Solution, 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 29 submissions below

Date	Submission	Status	Documents
Jan 30, 1985	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meperidine Hydrochloride50MG/5ML · syrup;oral	Meperidine Hydrochloride	Rx

All 29 submissions, including labeling and manufacturing supplements


Aug 28, 2026	Supplement 37Labeling · Standard review	Approved	None posted
Jun 18, 2026	Supplement 38REMS	Approved	None posted
Dec 22, 2025	Supplement 35Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 34REMS	Approved	None posted
Aug 13, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 32Labeling · Standard review	Approved	None posted
Dec 14, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Mar 4, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Oct 8, 2019	Supplement 29Labeling · Standard review	Approved	None posted
Oct 4, 2019	Supplement 28Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 27REMS	Approved	None posted
Apr 28, 2017	Supplement 26Labeling · Standard review	Approved	None posted
Mar 30, 2012	Supplement 23Labeling	Approved	None posted
May 18, 2011	Supplement 22Labeling	Approved	None posted
Apr 28, 2009	Supplement 21Labeling	Approved	None posted
Sep 26, 2005	Supplement 19Labeling	Approved	None posted
Jun 24, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 24, 1999	Supplement 16Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 15Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 14Manufacturing	Approved	None posted
Jan 10, 1997	Supplement 11Labeling	Approved	None posted
Jan 10, 1997	Supplement 10Manufacturing	Approved	None posted
Jan 10, 1997	Supplement 9Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 13Manufacturing	Approved	None posted
Aug 7, 1996	Supplement 12Manufacturing	Approved	None posted
Apr 5, 1990	Supplement 4Labeling	Approved	None posted
Sep 19, 1988	Supplement 2Manufacturing	Approved	None posted
Sep 19, 1988	Supplement 1Manufacturing	Approved	None posted
Jan 30, 1985	Original application	Approved	REMS

Identifiers

Application: ANDA 88744
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