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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
US Department of Justice
Harvard Business School
Express Scripts
Chinese Patent Office

Generated: January 17, 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
Ingredient:ethambutol hydrochloride
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 0555-0923-02 100 TABLET, FILM COATED in 1 BOTTLE (0555-0923-02)
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 076057 ANDA REMEDYREPACK INC. 70518-0751 70518-0751-0 30 TABLET, FILM COATED in 1 BLISTER PACK (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 leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice

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