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Details for New Drug Application (NDA): 204886

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NDA 204886 describes ZONTIVITY, which is a drug marketed by Aralez Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZONTIVITY profile page.

The generic ingredient in ZONTIVITY is vorapaxar sulfate. One supplier is listed for this compound. Additional details are available on the vorapaxar sulfate profile page.

Summary for NDA: 204886

Tradename:
ZONTIVITY
Applicant:
Aralez Pharms
Ingredient:
vorapaxar sulfate
Patents:2

Pharmacology for NDA: 204886

Suppliers and Packaging for NDA: 204886

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZONTIVITY
vorapaxar sulfate
TABLET;ORAL 204886 NDA Merck Sharp & Dohme Corp. 0006-0351 0006-0351-05 1 BLISTER PACK in 1 CARTON (0006-0351-05) > 5 TABLET, FILM COATED in 1 BLISTER PACK
ZONTIVITY
vorapaxar sulfate
TABLET;ORAL 204886 NDA Merck Sharp & Dohme Corp. 0006-0351 0006-0351-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0351-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.08MG BASE
Approval Date:May 8, 2014TE:RLD:Yes
Patent:7,235,567Patent Expiration:Jun 13, 2021Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:May 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,304,078Patent Expiration:Apr 6, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS


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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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