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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216384

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NDA 216384 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 216384

Tradename:	LEVOCARNITINE
Applicant:	Novitium Pharma
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 216384

Suppliers and Packaging for NDA: 216384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	TABLET;ORAL	216384	ANDA	ANI Pharmaceuticals, Inc.	70954-492	70954-492-10	90 BLISTER PACK in 1 CARTON (70954-492-10) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	330MG
Approval Date:	Dec 9, 2022	TE:	AB	RLD:	No

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