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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217430

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NDA 217430 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Deva Holding As, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms Inc, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the LEVOCARNITINE profile page.

The generic ingredient in LEVOCARNITINE is levocarnitine. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for 217430

Tradename:	LEVOCARNITINE
Applicant:	Deva Holding As
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 217430

Suppliers and Packaging for NDA: 217430

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	217430	ANDA	Devatis Inc.	73043-034	73043-034-05	5 VIAL in 1 CARTON (73043-034-05) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Jun 30, 2025	TE:	AP	RLD:	No

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