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Details for New Drug Application (NDA): 206500

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NDA 206500 describes VARUBI, which is a drug marketed by Tesaro Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the VARUBI profile page.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this compound. Additional details are available on the rolapitant hydrochloride profile page.

Summary for NDA: 206500

Tradename:
VARUBI
Applicant:
Tesaro Inc
Ingredient:
rolapitant hydrochloride
Patents:8

Suppliers and Packaging for NDA: 206500

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VARUBI
rolapitant hydrochloride
TABLET;ORAL 206500 NDA Tesaro, Inc. 69656-101 69656-101-02 2 TABLET in 1 BLISTER PACK (69656-101-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 90MG BASE
Approval Date:Sep 1, 2015TE:RLD:Yes
Patent:7,563,801Patent Expiration:Apr 4, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,178,550Patent Expiration:Apr 4, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:8,361,500Patent Expiration:Oct 9, 2029Product 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.

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