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Details for New Drug Application (NDA): 021923

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NDA 021923 describes NEXAVAR, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NEXAVAR profile page.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorafenib tosylate profile page.

Summary for NDA: 021923

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021923

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 021923

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sorafenib tosylate
TABLET;ORAL 021923 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-488 50419-488-58 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 20, 2005TE:RLD:Yes
Patent:7,235,576Patent Expiration:Jan 12, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:7,351,834Patent Expiration:Jan 12, 2020Product Flag?Substance Flag?YDelist Request?
Patent:7,897,623Patent Expiration:Jan 12, 2020Product Flag?YSubstance Flag?Delist Request?

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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.