Monodox

NDA 50641, held by Chartwell Rx. Doxycycline.

As of Nov 13, 2026, NDA 50641 (Monodox), held by Chartwell Rx, was first approved by FDA on Dec 29, 1989, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 29, 1989
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules and other antibacterial drugs, doxycycline capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 29, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
MonodoxEQ 100MG BASE · capsule;oral	Doxycycline	RxReference drug
MonodoxEQ 50MG BASE · capsule;oral	Doxycycline	RxReference drug
MonodoxEQ 75MG BASE · capsule;oral	Doxycycline	RxReference drug
MonodoxEQ 150MG BASE · capsule;oral	Doxycycline	RxReference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 2025	Supplement 34Labeling · Standard review	Approved	Letter Label
May 8, 2024	Supplement 33Labeling · Standard review	Approved	Label Letter
Feb 17, 2022	Supplement 32Manufacturing	Approved	Letter Label
Apr 3, 2017	Supplement 29Labeling · Standard review	Approved	Letter Label
Aug 5, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 11, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
Jan 11, 2012	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 8, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 20, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 31, 2007	Supplement 13Manufacturing	Approved	Letter
Jun 18, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Mar 21, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Jan 7, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 24, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 6, 1992	Supplement 5Labeling	Approved	None posted
Feb 10, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 15, 1991	Supplement 1Labeling	Approved	None posted
Nov 15, 1991	Supplement 4Labeling	Approved	None posted
Sep 25, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 29, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50641
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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