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Chinese Patent Office
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Dow

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078939

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NDA 078939 describes ETHAMBUTOL HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, and Lupin, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the ETHAMBUTOL HYDROCHLORIDE profile page.

The generic ingredient in ETHAMBUTOL HYDROCHLORIDE is ethambutol hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 078939
Tradename:ETHAMBUTOL HYDROCHLORIDE
Applicant:Lupin
Ingredient:ethambutol hydrochloride
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 078939
Medical Subject Heading (MeSH) Categories for 078939
Suppliers and Packaging for NDA: 078939
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939 ANDA American Health Packaging 68084-280 N 68084-280-01
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 078939 ANDA Carilion Materials Management 68151-0149 N 68151-0149-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jun 17, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jun 17, 2009TE:ABRLD:No

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