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Serving leading biopharmaceutical companies globally:

Fish and Richardson
QuintilesIMS
Teva
Moodys
Cantor Fitzgerald
Cerilliant
Queensland Health
Harvard Business School
Novartis
Citi

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075563

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NDA 075563 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-four 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-eight suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 075563
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:sotalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075563
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 075563
Suppliers and Packaging for NDA: 075563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563 ANDA Qualitest Pharmaceuticals 0603-5769 N 0603-5769-28
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075563 ANDA Qualitest Pharmaceuticals 0603-5769 N 0603-5769-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 7, 2003TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Nov 7, 2003TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Nov 7, 2003TE:AB1RLD:No

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Dow
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Daiichi Sankyo
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