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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 016320


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NDA 016320 describes MYAMBUTOL, which is a drug marketed by Kanchan Hlthcare and is included in one NDA. It is available from three suppliers. 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
Pharmacology for NDA: 016320
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 Marlex Pharmaceuticals, Inc. 10135-796 10135-796-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-796-01)
MYAMBUTOL ethambutol hydrochloride TABLET;ORAL 016320 NDA Marlex Pharmaceuticals, Inc. 10135-797 10135-797-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-797-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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