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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217430
Company: DEVA HOLDING AS

Products on ANDA 217430

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217430

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217430

LEVOCARNITINE

INJECTABLE;INJECTION; 200MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARNITOR	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020182	LEADIANT BIOSCI INC
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075861	AM REGENT
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217430	DEVA HOLDING AS
LEVOCARNITINE	LEVOCARNITINE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075567	HIKMA

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