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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 nine patents protecting this drug. Additional details are available on the VICTOZA profile page.

The generic ingredient in VICTOZA is liraglutide recombinant. There are six 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 NDA: 022341

Tradename:
VICTOZA
Applicant:
Novo Nordisk Inc
Ingredient:
liraglutide recombinant
Patents:9
Formulation / Manufacturing:see details

Pharmacology for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Jan 25, 2010TE:RLD:Yes
Patent:6,004,297Patent Expiration:Jan 28, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:7,235,627Patent Expiration:Aug 22, 2017Product Flag?YSubstance Flag?YDelist Request?
Patent:8,114,833Patent Expiration:Aug 13, 2025Product Flag?YSubstance Flag?Delist Request?


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