Last Updated: September 28, 2026

Details for New Drug Application (NDA): 075567

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NDA 075567 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Deva Holding As, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms, and is included in eleven NDAs. It is available from eight suppliers. Additional details are available on the LEVOCARNITINE profile page.

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

Summary for 075567

Tradename:	LEVOCARNITINE
Applicant:	Hikma
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 075567

Suppliers and Packaging for NDA: 075567

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	075567	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9852	0143-9852-10	10 VIAL, SINGLE-USE in 1 CARTON (0143-9852-10) / 5 mL in 1 VIAL, SINGLE-USE (0143-9852-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Mar 29, 2001	TE:	AP	RLD:	No

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