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Last Updated: April 9, 2026

Details for New Drug Application (NDA): 217063

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NDA 217063 describes LIRAGLUTIDE, which is a drug marketed by Biocon Pharma, Hikma, Lupin Ltd, Nanjing King Friend, Orbicular, and Teva Pharms, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the LIRAGLUTIDE profile page.

The generic ingredient in LIRAGLUTIDE is liraglutide. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the liraglutide profile page.

Summary for 217063

Tradename:	LIRAGLUTIDE
Applicant:	Biocon Pharma
Ingredient:	liraglutide
Patents:	0

Pharmacology for NDA: 217063

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Suppliers and Packaging for NDA: 217063

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	217063	ANDA	Biocon Pharma Inc.	70377-095	70377-095-52	3 SYRINGE, PLASTIC in 1 CARTON (70377-095-52) / 3 mL in 1 SYRINGE, PLASTIC
LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	217063	ANDA	Biocon Pharma Inc.	70377-095	70377-095-53	5 SYRINGE, PLASTIC in 1 CARTON (70377-095-53) / 3 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	18MG/3ML (6MG/ML)
Approval Date:	Feb 24, 2026	TE:	AP2	RLD:	No

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