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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

Tradename:
NEXAVAR
Applicant:
Bayer Hlthcare
Ingredient:
sorafenib tosylate
Patents:7
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
NEXAVAR
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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