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Generated: November 18, 2018

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Details for New Drug Application (NDA): 022341

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NDA 022341 describes VICTOZA, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VICTOZA profile page.

The generic ingredient in VICTOZA is liraglutide recombinant. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the liraglutide recombinant profile page.
Summary for 022341
Tradename:VICTOZA
Applicant:Novo Nordisk Inc
Ingredient:liraglutide recombinant
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 022341
Medical Subject Heading (MeSH) Categories for 022341
Suppliers and Packaging for NDA: 022341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341 NDA Novo Nordisk 0169-4060 0169-4060-12 2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) > 3 mL in 1 SYRINGE, PLASTIC
VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341 NDA Novo Nordisk 0169-4060 0169-4060-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) > 3 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Jan 25, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 22, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING TRIAL NN2211-3916, A TRIAL EVALUATING THE SAFETY AND EFFICACY OF LIRAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES AND MODERATE RENAL IMPAIRMENT
Regulatory Exclusivity Expiration:Aug 25, 2020
Regulatory Exclusivity Use:REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
Patent:➤ Sign UpPatent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?