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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 212533

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NDA 212533 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 212533

Tradename:	LEVOCARNITINE
Applicant:	Sciegen Pharms Inc
Ingredient:	levocarnitine
Patents:	0

Pharmacology for NDA: 212533

Suppliers and Packaging for NDA: 212533

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	SOLUTION;ORAL	212533	ANDA	TRUPHARMA, LLC	52817-830	52817-830-04	118 mL in 1 BOTTLE (52817-830-04)
LEVOCARNITINE	levocarnitine	SOLUTION;ORAL	212533	ANDA	Saptalis Pharmaceuticals, LLC	71656-016	71656-016-01	100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1GM/10ML
Approval Date:	Nov 10, 2021	TE:	AA	RLD:	No

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