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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076057

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NDA 076057 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 076057
Tradename:ETHAMBUTOL HYDROCHLORIDE
Applicant:Barr
Ingredient:ethambutol hydrochloride
Patents:0
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 076057
Medical Subject Heading (MeSH) Categories for 076057
Suppliers and Packaging for NDA: 076057
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 076057 ANDA Barr Laboratories Inc. 0555-0923 N 0555-0923-02
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 076057 ANDA REMEDYREPACK INC. 70518-0751 N 70518-0751-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Nov 26, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Deloitte
US Army
Citi
Healthtrust
Cantor Fitzgerald
Queensland Health
Teva
Chubb

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