Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Chinese Patent Office
Argus Health
Daiichi Sankyo

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078939

« Back to Dashboard

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. Thirteen suppliers are listed for this compound. Additional details are available on the ethambutol hydrochloride profile page.
Summary for 078939
Ingredient:ethambutol hydrochloride
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.