Minocin

NDA 50444, held by Rempex. Minocycline Hydrochloride.

As of Nov 13, 2026, NDA 50444 (Minocin), held by Rempex, was first approved by FDA on Oct 26, 1972, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1972
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MINOCIN Intravenous is indicated in the treatment of the following infections due to susceptible isolates of the designated bacteria: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below


Mar 21, 1975	Supplement 16Efficacy (new indication or use)	Approved	None posted
Oct 26, 1972	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MinocinEQ 100MG BASE/VIAL · injectable;injection	Minocycline Hydrochloride	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Mar 31, 2025	Supplement 53Labeling · Standard review	Approved	Letter Label
Oct 23, 2014	Supplement 48Labeling · Standard review	Approved	None posted
Sep 14, 2010	Supplement 47Labeling · Standard review	Approved	None posted
Jan 16, 2007	Supplement 45Labeling · Standard review	Approved	None posted
Sep 28, 2005	Supplement 44Labeling · Standard review	Approved	None posted
Feb 17, 2005	Supplement 38Labeling · Standard review	Approved	None posted
May 27, 2004	Supplement 43Labeling · Standard review	Approved	None posted
May 27, 2004	Supplement 42Labeling · Standard review	Approved	None posted
May 31, 2002	Supplement 36Labeling · Standard review	Approved	None posted
Jan 30, 2002	Supplement 34Labeling · Standard review	Approved	None posted
Jan 30, 2002	Supplement 33Labeling · Standard review	Approved	None posted
Jan 30, 2002	Supplement 29Labeling · Standard review	Approved	None posted
Mar 29, 1996	Supplement 31Labeling · Standard review	Approved	None posted
May 12, 1992	Supplement 9Labeling	Approved	None posted
Aug 28, 1991	Supplement 8Labeling	Approved	None posted
Oct 6, 1987	Supplement 4Labeling	Approved	None posted
Jan 10, 1986	Supplement 2Labeling	Approved	None posted
Apr 12, 1978	Supplement 27Labeling	Approved	None posted
Mar 21, 1975	Supplement 16Efficacy (new indication or use)	Approved	None posted
Nov 4, 1974	Supplement 14Labeling	Approved	None posted
Oct 4, 1973	Supplement 13Labeling	Approved	None posted
Oct 26, 1972	Original application	Approved	None posted

Identifiers

Application: NDA 50444
Drugs@FDA: Overview at FDA
Company: Rempex Pharmaceuticals

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