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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077070

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NDA 077070 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-three 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-seven suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

Summary for 077070

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077070

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Medical Subject Heading (MeSH) Categories for 077070

Suppliers and Packaging for NDA: 077070

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 077070 ANDA Epic Pharma, LLC 42806-121 42806-121-01 100 TABLET in 1 BOTTLE (42806-121-01)
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 077070 ANDA Epic Pharma, LLC 42806-121 42806-121-10 1000 TABLET in 1 BOTTLE (42806-121-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 4, 2005TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Nov 4, 2005TE:AB2RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Nov 4, 2005TE:AB2RLD:No


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