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Details for New Drug Application (NDA): 022023

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NDA 022023 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: 022023

Tradename:
EMEND
Applicant:
Merck And Co Inc
Ingredient:
fosaprepitant dimeglumine
Patents:1

Suppliers and Packaging for NDA: 022023

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS 022023 NDA Merck Sharp & Dohme Corp. 0006-3941 0006-3941-32 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-3941-32) > 5 mL in 1 VIAL, SINGLE-DOSE (0006-3941-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INTRAVENOUSStrengthEQ 115MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 25, 2008TE:RLD:No
Patent:5,691,336Patent Expiration:Mar 4, 2019Product Flag?YSubstance Flag?YDelist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 150MG BASE/VIAL
Approval Date:Nov 12, 2010TE:APRLD:Yes
Patent:5,691,336Patent Expiration:Mar 4, 2019Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Feb 1, 2019
Regulatory Exclusivity Use:SINGLE IV DOSE OF FOSAPREPITANT 150MG DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR ANTAGONIST & CORTICOSTEROID FOR PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF MODERATELY EMETOGENIC CANCER CHEMOTHERAPY

Expired Orange Book Patents for NDA: 022023

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-001Jan 25, 20085,512,570► subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 20105,512,570► subscribe
Merck And Co Inc
EMEND
fosaprepitant dimeglumine
POWDER;INTRAVENOUS022023-002Nov 12, 20105,716,942► subscribe
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