Meperidine Hydrochloride

ANDA 80454, held by Wyeth Ayerst. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 80454 (Meperidine Hydrochloride), held by Wyeth Ayerst, was first approved by FDA on Jul 31, 1973, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1973
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
Jul 31, 1973	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Mar 4, 1992	Supplement 17Labeling	Approved	None posted
Feb 22, 1990	Supplement 11Manufacturing	Approved	None posted
Jan 22, 1990	Supplement 12Labeling	Approved	None posted
Jan 22, 1990	Supplement 13Labeling	Approved	None posted
Jan 22, 1990	Supplement 15Bioequivalence	Approved	None posted
Nov 24, 1987	Supplement 10Manufacturing	Approved	None posted
Jan 23, 1984	Supplement 5Manufacturing	Approved	None posted
Jan 23, 1984	Supplement 6Manufacturing	Approved	None posted
Oct 3, 1983	Supplement 3Manufacturing	Approved	None posted
Oct 3, 1983	Supplement 4Manufacturing	Approved	None posted
Jul 31, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80454
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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