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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075095

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NDA 075095 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 075095
Tradename:ETHAMBUTOL HYDROCHLORIDE
Applicant:Akorn
Ingredient:ethambutol hydrochloride
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 075095
Medical Subject Heading (MeSH) Categories for 075095
Suppliers and Packaging for NDA: 075095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 075095 ANDA Physicians Total Care, Inc. 54868-6219 E 54868-6219-0
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 075095 ANDA VersaPharm Incorporated 61748-011 N 61748-011-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 30, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 30, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Boehringer Ingelheim
Federal Trade Commission
Fuji
Chinese Patent Office
US Department of Justice
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