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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 076851

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NDA 076851 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms Inc, and is included in nine NDAs. It is available from six 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. Seven suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for 076851

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

Pharmacology for NDA: 076851

Suppliers and Packaging for NDA: 076851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	SOLUTION;ORAL	076851	ANDA	Rising Pharma Holdings, Inc.	64980-503	64980-503-12	118 mL in 1 BOTTLE, PLASTIC (64980-503-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1GM/10ML
Approval Date:	Aug 10, 2004	TE:	AA	RLD:	No

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