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Details for New Drug Application (NDA): 203085

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NDA 203085 describes STIVARGA, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the STIVARGA profile page.

The generic ingredient in STIVARGA is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Summary for NDA: 203085

Bayer Hlthcare

Pharmacology for NDA: 203085

Suppliers and Packaging for NDA: 203085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 203085 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-171 50419-171-00 210 BOTTLE in 1 BOX (50419-171-00) > 28 TABLET, FILM COATED in 1 BOTTLE
TABLET;ORAL 203085 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-171 50419-171-03 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Sep 27, 2012TE:RLD:Yes
Patent:7,351,834Patent Expiration:Jan 12, 2020Product Flag?Substance Flag?YDelist Request?
Patent:8,637,553Patent Expiration:Feb 16, 2031Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Sep 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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.