Meperidine Hydrochloride Preservative Free

ANDA 73443, held by Watson Labs. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 73443 (Meperidine Hydrochloride Preservative Free), held by Watson Labs, was first approved by FDA on Mar 17, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 17, 1992
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 17, 1992	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Dec 16, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Feb 19, 1999	Supplement 7Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 4Manufacturing	Approved	None posted
Jul 12, 1995	Supplement 2Manufacturing	Approved	None posted
Sep 27, 1994	Supplement 1Labeling	Approved	None posted
Mar 17, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73443
Drugs@FDA: Overview at FDA
Company: Watson 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