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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Teva
US Department of Justice
Cerilliant
Moodys
Johnson and Johnson
Chinese Patent Office
Medtronic
McKesson

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076576

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NDA 076576 describes SOTALOL HYDROCHLORIDE, which is a drug marketed by Altathera Pharms Llc, Apotex, Apotex Inc, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Sun Pharm Industries, Teva, Upsher-smith Labs, Vintage Pharms, and Watson Labs, and is included in sixteen NDAs. It is available from twenty-two suppliers. Additional details are available on the SOTALOL HYDROCHLORIDE profile page.

The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 076576
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:sotalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076576

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength80MG
Approval Date:Apr 8, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength120MG
Approval Date:Apr 8, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength160MG
Approval Date:Apr 8, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Argus Health
Moodys
Merck
McKinsey
Cerilliant
McKesson
Dow

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