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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075861

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NDA 075861 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 075861

Tradename:	LEVOCARNITINE
Applicant:	Am Regent
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 075861

Suppliers and Packaging for NDA: 075861

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	075861	ANDA	American Regent, Inc.	0517-1045	0517-1045-05	5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01)
LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	075861	ANDA	American Regent, Inc.	0517-1075	0517-1075-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Jun 22, 2001	TE:	AP	RLD:	No

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