Meperidine Hydrochloride

Manages pain severe enough to require an opioid analgesic. ANDA 80445, held by West-Ward Pharms Int. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 80445 (Meperidine Hydrochloride), held by West-Ward Pharms Int, was first approved by FDA on Jan 22, 1975, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 22, 1975
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. Meperidine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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
Jan 22, 1975	Original application	Approved	None posted

Products

4 strengths and forms


Meperidine Hydrochloride25MG/ML · injectable;injection	Meperidine Hydrochloride	Rx
Meperidine Hydrochloride50MG/ML · injectable;injection	Meperidine Hydrochloride	Rx
Meperidine Hydrochloride75MG/ML · injectable;injection	Meperidine Hydrochloride	Rx
Meperidine Hydrochloride100MG/ML · injectable;injection	Meperidine Hydrochloride	Rx

All 17 submissions, including labeling and manufacturing supplements


Oct 11, 2024	Supplement 52Labeling · Standard review	Approved	None posted
Aug 10, 2023	Supplement 45Labeling · Standard review	Approved	None posted
Aug 10, 2023	Supplement 51Labeling · Standard review	Approved	None posted
Apr 28, 2005	Supplement 38Labeling	Approved	None posted
Apr 10, 2002	Supplement 35Manufacturing	Approved	None posted
Apr 30, 1996	Supplement 26Manufacturing	Approved	None posted
Sep 22, 1995	Supplement 22Manufacturing	Approved	None posted
Mar 13, 1992	Supplement 21Labeling	Approved	None posted
Oct 16, 1991	Supplement 20Labeling	Approved	None posted
Apr 3, 1991	Supplement 19Labeling	Approved	None posted
Dec 18, 1990	Supplement 18Labeling	Approved	None posted
Sep 19, 1989	Supplement 17Labeling	Approved	None posted
Jul 20, 1989	Supplement 16Labeling	Approved	None posted
Dec 28, 1988	Supplement 14Labeling	Approved	None posted
Nov 3, 1986	Supplement 11Manufacturing	Approved	None posted
Mar 8, 1983	Supplement 10Manufacturing	Approved	None posted
Jan 22, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 80445
Drugs@FDA: Overview at FDA
Company: West-Ward Pharms Int

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