Minocin

NDA 50649, held by Bausch. Minocycline Hydrochloride.

As of Nov 13, 2026, NDA 50649 (Minocin), held by Bausch, was first approved by FDA on May 31, 1990, with 29 approved supplements and 0 published complete response letters.

First approved: May 31, 1990
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
May 31, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
MinocinEQ 50MG BASE · capsule;oral	Minocycline Hydrochloride	RxReference drug
MinocinEQ 100MG BASE · capsule;oral	Minocycline Hydrochloride	RxReference drug
MinocinEQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Minocycline Hydrochloride	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 18, 2024	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 19, 2017	Supplement 27Labeling · Standard review	Approved	Letter Label
Dec 14, 2016	Supplement 26Labeling · Standard review	Approved	Letter Label
Mar 9, 2015	Supplement 25Labeling · Standard review	Approved	Label Letter
May 29, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 14, 2010	Supplement 23Labeling	Approved	Label Letter
Jun 30, 2008	Supplement 22Labeling · Standard review	Approved	Letter Label
May 30, 2007	Supplement 21Manufacturing	Approved	Letter
Apr 2, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 23, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 28, 2005	Supplement 18Labeling · Standard review	Approved	Letter
Feb 17, 2005	Supplement 15Labeling · Standard review	Approved	Letter
May 27, 2004	Supplement 17Labeling · Standard review	Approved	Letter
May 27, 2004	Supplement 16Labeling · Standard review	Approved	Letter
May 31, 2002	Supplement 11Labeling · Standard review	Approved	Review Letter
Feb 1, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Feb 1, 2002	Supplement 5Labeling · Standard review	Approved	Letter
Jan 28, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 29, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 12, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 5, 1998	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 5, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 5, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 8, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Jan 28, 1993	Supplement 4Manufacturing · Standard review	Approved	None posted
May 12, 1992	Supplement 3Labeling	Approved	None posted
Mar 26, 1992	Supplement 2Labeling	Approved	None posted
Oct 9, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
May 31, 1990	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50649
Drugs@FDA: Overview at FDA
Company: Bausch Health

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