Demerol

NDA 21171, held by Hospira. Meperidine Hydrochloride.

First approved: Nov 10, 1942
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Nov 10, 1942	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Demerol25MG/ML · injectable;injection	Meperidine Hydrochloride	Rx · reference drug
Demerol50MG/ML · injectable;injection	Meperidine Hydrochloride	Rx · reference drug
Demerol75MG/ML · injectable;injection	Meperidine Hydrochloride	Rx · reference drug
Demerol100MG/ML · injectable;injection	Meperidine Hydrochloride	Rx · reference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 22, 2025	Supplement 63Labeling · Standard review	Approved	Label Letter
Jan 7, 2025	Supplement 60Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 53Labeling · Standard review	Approved	Letter Label
Oct 21, 2022	Supplement 51Labeling · Standard review	Approved	Label
Oct 7, 2019	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
Jun 24, 2016	Supplement 23Manufacturing	Approved	None posted
Apr 19, 2013	Supplement 20Manufacturing	Approved	None posted
Aug 24, 2001	Supplement 4Manufacturing	Approved	None posted
Jan 31, 2001	Supplement 3Manufacturing	Approved	None posted
Dec 9, 1999	Supplement 2Labeling · Standard review	Approved	None posted
Nov 17, 1998	Supplement 1Manufacturing	Approved	None posted
Nov 10, 1942	Original application	Approved	None posted

Identifiers

Application: NDA 21171
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters