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Last Updated: May 25, 2022

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 two suppliers. 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. Eighty-three 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022450
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 Mallinckrodt Hospital Products Inc. 43825-102 43825-102-01 24 VIAL, GLASS in 1 CARTON (43825-102-01) > 100 mL in 1 VIAL, GLASS
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:DISCNDosage:SOLUTION;INTRAVENOUSStrength1GM/100ML (10MG/ML)
Approval Date:Nov 2, 2010TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Nov 13, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
Patent:See Plans and PricingPatent Expiration:Nov 13, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
Patent:See Plans and PricingPatent Expiration:Mar 11, 2032Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022450

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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