Meperidine Hydrochloride

ANDA 80448, held by Sun Pharm Industries. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 80448 (Meperidine Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Oct 15, 1976, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 15, 1976
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 15, 1976	Original application	Approved	REMS

Products

2 strengths and forms


Meperidine Hydrochloride50MG · tablet;oral	Meperidine Hydrochloride	Discontinued
Meperidine Hydrochloride100MG · tablet;oral	Meperidine Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 26REMS	Approved	None posted
Dec 22, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Oct 31, 2024	Supplement 24REMS	Approved	None posted
Apr 30, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Dec 15, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 21REMS	Approved	None posted
May 8, 1992	Supplement 18Labeling	Approved	None posted
Mar 16, 1989	Supplement 17Labeling	Approved	None posted
Aug 14, 1986	Supplement 15Manufacturing	Approved	None posted
Oct 28, 1983	Supplement 13Manufacturing	Approved	None posted
Oct 15, 1976	Original application	Approved	REMS

Identifiers

Application: ANDA 80448
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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