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Generated: January 17, 2019

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Details for New Drug Application (NDA): 207865

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NDA 207865 describes EMEND, which is a drug marketed by Merck, Msd Merck Co, and Merck And Co Inc, and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug and four Paragraph IV challenges. Additional details are available on the EMEND profile page.

The generic ingredient in EMEND is fosaprepitant dimeglumine. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.
Summary for 207865
Tradename:EMEND
Applicant:Msd Merck Co
Ingredient:aprepitant
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207865
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMEND aprepitant FOR SUSPENSION;ORAL 207865 NDA Merck Sharp & Dohme Corp. 0006-3066 0006-3066-03 1 POUCH in 1 CARTON (0006-3066-03) > 1 POWDER, FOR SUSPENSION in 1 POUCH (0006-3066-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/KIT
Approval Date:Dec 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 28, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Jul 1, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY (CINV)
Patent:➤ Try a Free TrialPatent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY (CINV)

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Serving hundreds of leading biopharmaceutical companies globally:

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Dow
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