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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214568
Company: TEVA PHARMS

Products on ANDA 214568

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIRAGLUTIDE	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214568

LIRAGLUTIDE

SOLUTION;SUBCUTANEOUS; 18MG/3ML (6MG/ML)
TE Code = AP2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIRAGLUTIDE	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP2	214568	TEVA PHARMS
SAXENDA	LIRAGLUTIDE	18MG/3ML (6MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP2	206321	NOVO

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