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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076214

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NDA 076214 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 076214

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

Pharmacology for NDA: 076214

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Medical Subject Heading (MeSH) Categories for 076214

Suppliers and Packaging for NDA: 076214

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076214 ANDA AvKARE, Inc. 42291-760 42291-760-01 100 TABLET in 1 BOTTLE (42291-760-01)
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 076214 ANDA AvKARE, Inc. 42291-761 42291-761-01 100 TABLET in 1 BOTTLE (42291-761-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Aug 27, 2003TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Aug 27, 2003TE:AB2RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Aug 27, 2003TE:AB2RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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