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 one supplier. There is one patent 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 eleven drug master file entries for this compound. Twenty-three suppliers are 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:	1

Pharmacology for NDA: 207865

Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

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 LLC	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:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	125MG/KIT
Approval Date:	Dec 17, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH CHEMOTHERAPY (CINV)

Expired US Patents for NDA 207865

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Merck Co	EMEND	aprepitant	FOR SUSPENSION;ORAL	207865-001	Dec 17, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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