Morphine Sulfate (Autoinjector)

NDA 19999, held by Meridian Medcl Techn. Morphine Sulfate.

As of Nov 13, 2026, NDA 19999 (Morphine Sulfate (Autoinjector)), held by Meridian Medcl Techn, was first approved by FDA on Jul 12, 1990, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 12, 1990
Review: Standard
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
Jul 12, 1990	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate (Autoinjector)10MG/0.7ML (10MG/0.7ML) · solution;intramuscular	Morphine Sulfate	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 7, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 9, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 14, 2013	Supplement 19Manufacturing · Standard review	Approved	None posted
May 29, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 18, 2001	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 21, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 14, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 13, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 23, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 28, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 27, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 12, 1990	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19999
Drugs@FDA: Overview at FDA
Company: Meridian Medcl Techn

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