Details for New Drug Application (NDA): 016320

NDA 016320 describes MYAMBUTOL, which is a drug marketed by Kanchan Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the MYAMBUTOL profile page.

The generic ingredient in MYAMBUTOL is ethambutol hydrochloride. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.

Summary for 016320

Tradename:	MYAMBUTOL
Applicant:	Kanchan Hlthcare
Ingredient:	ethambutol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 016320

Antitubercular Agents

Suppliers and Packaging for NDA: 016320

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYAMBUTOL	ethambutol hydrochloride	TABLET;ORAL	016320	NDA AUTHORIZED GENERIC	STI Pharma LLC	54879-001	54879-001-01	12 CARTON in 1 BOX (54879-001-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
MYAMBUTOL	ethambutol hydrochloride	TABLET;ORAL	016320	NDA AUTHORIZED GENERIC	STI Pharma LLC	54879-002	54879-002-01	12 CARTON in 1 BOX (54879-002-01) / 12 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

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