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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 And Co Inc, Merck, and Msd Merck Co, and is included in three NDAs. It is available from three suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the EMEND profile page.

The generic ingredient in EMEND is aprepitant. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

Summary for NDA: 207865

Msd Merck Co
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 207865

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

Summary 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

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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.