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Generated: May 26, 2017

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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 two suppliers. There are two patents protecting this drug. Additional details are available on the ZONTIVITY profile page.

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

Summary for NDA: 204886


Pharmacology for NDA: 204886

Suppliers and Packaging for NDA: 204886

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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?

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