Last Updated: November 9, 2026

Details for New Drug Application (NDA): 220181

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NDA 220181 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Baxter Hlthcare Corp, Deva Holding As, Gland, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms, and is included in twelve NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for 220181

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

Pharmacology for NDA: 220181

Suppliers and Packaging for NDA: 220181

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	220181	ANDA	Gland Pharma Limited	68083-681	68083-681-05	5 VIAL, SINGLE-DOSE in 1 CARTON (68083-681-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Sep 30, 2026	TE:	AP	RLD:	No

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