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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Harvard Business School
Queensland Health
Chinese Patent Office

Generated: August 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075500

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NDA 075500 describes SORINE, which is a drug marketed by Upsher-smith Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the SORINE profile page.

The generic ingredient in SORINE 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 NDA: 075500

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075500

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Suppliers and Packaging for NDA: 075500

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sotalol hydrochloride
TABLET;ORAL 075500 ANDA Upsher-Smith Laboratories, Inc. 0245-0012 0245-0012-01 100 BLISTER PACK in 1 CARTON (0245-0012-01) > 1 TABLET in 1 BLISTER PACK (0245-0012-89)
sotalol hydrochloride
TABLET;ORAL 075500 ANDA Upsher-Smith Laboratories, Inc. 0245-0012 0245-0012-11 100 TABLET in 1 BOTTLE (0245-0012-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Apr 27, 2001TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Apr 27, 2001TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
Approval Date:Apr 27, 2001TE:AB1RLD:No

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Daiichi Sankyo
Fish and Richardson

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