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Generated: May 29, 2017

DrugPatentWatch Database Preview

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

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:
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

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