Meperidine Hydrochloride

ANDA 80455, held by West-Ward Pharms Int. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 80455 (Meperidine Hydrochloride), held by West-Ward Pharms Int, was first approved by FDA on Apr 26, 1972, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1972
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 26, 1972	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 10 submissions, including labeling and manufacturing supplements


Nov 10, 1998	Supplement 28Manufacturing	Approved	None posted
Jan 17, 1996	Supplement 27Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 24Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 26Manufacturing	Approved	None posted
Mar 4, 1992	Supplement 25Labeling	Approved	None posted
Jan 22, 1990	Supplement 23Labeling	Approved	None posted
May 23, 1988	Supplement 21Labeling	Approved	None posted
Mar 27, 1987	Supplement 18Manufacturing	Approved	None posted
Dec 2, 1983	Supplement 14Manufacturing	Approved	None posted
Apr 26, 1972	Original application	Approved	None posted

Identifiers

Application: ANDA 80455
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