Myambutol

Treats pulmonary tuberculosis. NDA 16320, held by Kanchan Hlthcare. Ethambutol Hydrochloride.

As of Nov 13, 2026, NDA 16320 (Myambutol), held by Kanchan Hlthcare, was first approved by FDA on Nov 6, 1967, with 33 approved supplements and 0 published complete response letters.

First approved: Nov 6, 1967
Review: Priority
Supplements approved: 33
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS ETHAMBUTOL HCl is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following: ETHAMBUTOL HCl plus isoniazid ETHAMBUTOL HCl plus isoniazid plus streptomycin.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Nov 6, 1967	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

4 strengths and forms


Myambutol100MG · tablet;oral	Ethambutol Hydrochloride	RxReference drug
Myambutol200MG · tablet;oral	Ethambutol Hydrochloride	Discontinued
Myambutol400MG · tablet;oral	Ethambutol Hydrochloride	RxReference drug
Myambutol500MG · tablet;oral	Ethambutol Hydrochloride	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Feb 22, 2013	Supplement 66Manufacturing · Priority review	Approved	Label
Oct 30, 2008	Supplement 63Labeling · Standard review	Approved	Label Letter
Mar 24, 2004	Supplement 60Labeling · Standard review	Approved	Label Letter
Feb 6, 2003	Supplement 58Labeling · Standard review	Approved	Letter Label
Feb 6, 2003	Supplement 57Labeling · Standard review	Approved	Label Letter
Oct 10, 2001	Supplement 56Labeling · Standard review	Approved	Label
May 14, 1998	Supplement 55Manufacturing · Priority review	Approved	None posted
May 8, 1998	Supplement 54Manufacturing · Priority review	Approved	None posted
Jun 20, 1995	Supplement 53Manufacturing · Priority review	Approved	None posted
Nov 23, 1987	Supplement 51Manufacturing · Priority review	Approved	None posted
Nov 2, 1987	Supplement 52Manufacturing · Priority review	Approved	None posted
Jun 25, 1987	Supplement 46Labeling	Approved	None posted
May 19, 1987	Supplement 50Manufacturing · Priority review	Approved	None posted
Jan 3, 1986	Supplement 49Manufacturing · Priority review	Approved	None posted
Sep 12, 1985	Supplement 47Manufacturing · Priority review	Approved	None posted
Feb 24, 1982	Supplement 44Manufacturing · Priority review	Approved	None posted
Nov 3, 1981	Supplement 43Manufacturing · Priority review	Approved	None posted
Aug 18, 1981	Supplement 42Manufacturing · Priority review	Approved	None posted
Aug 18, 1981	Supplement 41Manufacturing · Priority review	Approved	None posted
Jul 29, 1981	Supplement 40Manufacturing · Priority review	Approved	None posted
Jan 9, 1981	Supplement 39Manufacturing · Priority review	Approved	None posted
Apr 3, 1979	Supplement 38Manufacturing · Priority review	Approved	None posted
Apr 3, 1979	Supplement 37Manufacturing · Priority review	Approved	None posted
Dec 21, 1978	Supplement 36Labeling	Approved	None posted
Jun 27, 1978	Supplement 34Manufacturing · Priority review	Approved	None posted
Jun 26, 1978	Supplement 35Manufacturing · Priority review	Approved	None posted
May 3, 1978	Supplement 33Manufacturing · Priority review	Approved	None posted
Apr 7, 1978	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 5, 1977	Supplement 31Manufacturing · Priority review	Approved	None posted
May 13, 1977	Supplement 30Manufacturing · Priority review	Approved	None posted
Jun 10, 1976	Supplement 29Manufacturing · Priority review	Approved	None posted
Apr 28, 1976	Supplement 28Manufacturing · Priority review	Approved	None posted
Feb 21, 1975	Supplement 27Manufacturing · Priority review	Approved	None posted
Nov 6, 1967	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16320
Drugs@FDA: Overview at FDA
Company: Kanchan Healthcare

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