Meperidine Hydrochloride

ANDA 88639, held by Barr. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 88639 (Meperidine Hydrochloride), held by Barr, was first approved by FDA on Jul 2, 1984, with 35 approved supplements and 0 published complete response letters.

First approved: Jul 2, 1984
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Jul 2, 1984	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meperidine Hydrochloride50MG · tablet;oral	Meperidine Hydrochloride	Discontinued

All 36 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 52REMS	Approved	None posted
Dec 22, 2025	Supplement 50Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 49REMS	Approved	None posted
Apr 16, 2024	Supplement 48Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 47Labeling · Standard review	Approved	None posted
Dec 18, 2023	Supplement 46Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 45Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 41Labeling · Standard review	Approved	None posted
Dec 13, 2023	Supplement 38Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 40REMS	Approved	None posted
May 29, 2015	Supplement 34Labeling	Approved	None posted
May 29, 2015	Supplement 33Labeling	Approved	None posted
May 29, 2015	Supplement 32Labeling	Approved	None posted
Sep 2, 2009	Supplement 31Labeling	Approved	None posted
Mar 2, 2004	Supplement 27Labeling	Approved	None posted
Jul 27, 2001	Supplement 26Manufacturing	Approved	None posted
Jul 27, 2001	Supplement 25Manufacturing	Approved	None posted
Oct 30, 2000	Supplement 23Manufacturing	Approved	None posted
Dec 21, 1999	Supplement 22Manufacturing	Approved	None posted
May 20, 1999	Supplement 21Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 20Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 19Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 18Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 17Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 16Manufacturing	Approved	None posted
Jan 24, 1997	Supplement 15Manufacturing	Approved	None posted
Dec 23, 1994	Supplement 14Manufacturing	Approved	None posted
Mar 2, 1994	Supplement 13Labeling	Approved	None posted
Apr 3, 1992	Supplement 12Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 10Manufacturing	Approved	None posted
Jul 30, 1991	Supplement 9Labeling	Approved	None posted
Jan 3, 1990	Supplement 5Manufacturing	Approved	None posted
Oct 27, 1989	Supplement 8Labeling	Approved	None posted
Oct 10, 1989	Supplement 7Labeling	Approved	None posted
Apr 30, 1985	Supplement 3Manufacturing	Approved	None posted
Jul 2, 1984	Original application	Approved	REMS

Identifiers

Application: ANDA 88639
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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