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Details for New Drug Application (NDA): 022450

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NDA 022450 describes OFIRMEV, which is a drug marketed by Mallinckrodt Ip and is included in one NDA. It is available from two suppliers. There are three 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-five drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the acetaminophen profile page.

Summary for NDA: 022450

Tradename:
OFIRMEV
Applicant:
Mallinckrodt Ip
Ingredient:
acetaminophen
Patents:3
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OFIRMEV
acetaminophen
SOLUTION;IV (INFUSION) 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;IV (INFUSION) 022450 NDA Mallinckrodt Hospital Products Inc. 43825-102 43825-102-03 24 BAG in 1 CARTON (43825-102-03) > 100 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength1GM/100ML (10MG/ML)
Approval Date:Nov 2, 2010TE:APRLD:Yes
Patent:6,028,222*PEDPatent Expiration:Feb 5, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,992,218*PEDPatent Expiration:Dec 6, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:9,399,012*PEDPatent Expiration:Mar 11, 2032Product Flag?Substance Flag?Delist Request?Y


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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