Details for New Drug Application (NDA): 022450

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NDA 022450 describes OFIRMEV, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the OFIRMEV profile page.

The generic ingredient in OFIRMEV is acetaminophen. There are sixty-six drug master file entries for this compound. Ninety-four suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

Summary for 022450

Tradename:	OFIRMEV
Applicant:	Mallinckrodt Hosp
Ingredient:	acetaminophen
Patents:	4

Medical Subject Heading (MeSH) Categories for 022450

Analgesics, Non-Narcotic
Antipyretics

Suppliers and Packaging for NDA: 022450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1424	51662-1424-1	100 mL in 1 VIAL, GLASS (51662-1424-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 2, 2010	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 13, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
Patent:	⤷ Sign Up	Patent Expiration:	Nov 13, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
Patent:	⤷ Sign Up	Patent Expiration:	Mar 11, 2032	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022450

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	⤷ Sign Up	⤷ Sign Up
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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