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Serving leading biopharmaceutical companies globally:

Covington
Deloitte
US Army
Medtronic
Queensland Health
Fuji
UBS
McKesson
Novartis
Moodys

Generated: December 16, 2017

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:1
Applicant:1
Ingredient:1
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 54868-6219-0 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6219-0)
ETHAMBUTOL HYDROCHLORIDE ethambutol hydrochloride TABLET;ORAL 075095 ANDA VersaPharm Incorporated 61748-011 61748-011-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61748-011-01)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Deloitte
Queensland Health
Express Scripts
Accenture
McKesson
Fish and Richardson
Johnson and Johnson
Argus Health

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