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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075429

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NDA 075429 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 075429
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Teva
Ingredient:sotalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075429
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 075429
Suppliers and Packaging for NDA: 075429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429 ANDA Teva Pharmaceuticals USA, Inc. 0093-1060 N 0093-1060-01
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 075429 ANDA Teva Pharmaceuticals USA, Inc. 0093-1061 N 0093-1061-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:May 1, 2000TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:May 1, 2000TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:May 1, 2000TE:AB1RLD:No

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