Meperidine Hydrochloride Preservative Free

ANDA 40305, held by Hospira. Meperidine Hydrochloride.

As of Nov 15, 2026, ANDA 40305 (Meperidine Hydrochloride Preservative Free), held by Hospira, was first approved by FDA on Mar 10, 1999, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 10, 1999
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 10, 1999	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 3 submissions, including labeling and manufacturing supplements


Jun 6, 2002	Supplement 3Manufacturing	Approved	None posted
Nov 7, 2000	Supplement 1Manufacturing	Approved	None posted
Mar 10, 1999	Original application	Approved	None posted

Identifiers

Application: ANDA 40305
Drugs@FDA: Overview at FDA
Company: Hospira

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