Meperidine Hydrochloride Preservative Free

ANDA 81002, held by West-Ward Pharms Int. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 81002 (Meperidine Hydrochloride Preservative Free), held by West-Ward Pharms Int, was first approved by FDA on Jul 30, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1993
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jul 30, 1993	Original application	Approved	Other

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meperidine Hydrochloride Preservative Free10MG/ML · injectable;injection	Meperidine Hydrochloride	Rx

All 13 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jan 3, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Oct 11, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Sep 23, 2019	Supplement 9Labeling · Standard review	Approved	None posted
May 2, 2017	Supplement 8Labeling · Standard review	Approved	None posted
May 31, 1996	Supplement 6Manufacturing	Approved	None posted
Sep 5, 1995	Supplement 4Labeling	Approved	None posted
Sep 5, 1995	Supplement 5Labeling	Approved	None posted
Aug 29, 1995	Supplement 3Manufacturing	Approved	None posted
Sep 29, 1994	Supplement 1Manufacturing	Approved	None posted
Jun 10, 1994	Supplement 2Labeling	Approved	None posted
Jul 30, 1993	Original application	Approved	Other

Identifiers

Application: ANDA 81002
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