Details for New Drug Application (NDA): 216686

NDA 216686 describes FOCINVEZ, which is a drug marketed by Steriscience and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the FOCINVEZ profile page.

The generic ingredient in FOCINVEZ 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 216686

Tradename:	FOCINVEZ
Applicant:	Steriscience
Ingredient:	fosaprepitant dimeglumine
Patents:	2

Pharmacology for NDA: 216686

Mechanism of Action

Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Suppliers and Packaging for NDA: 216686

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686	NDA	Amneal Pharmaceuticals LLC	70121-2631	70121-2631-1	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2631-1) / 50 mL in 1 VIAL, SINGLE-DOSE
FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686	NDA	Spes Pharmaceuticals Inc.	82243-1001	82243-1001-1	1 VIAL, SINGLE-DOSE in 1 CARTON (82243-1001-1) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 150MG BASE/50ML (EQ 3MG BASE/ML)
Approval Date:	Aug 22, 2023	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jan 11, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Jan 11, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

Complete Access Available with Subscription