You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216384

✉ Email this page to a colleague

« Back to Dashboard

NDA 216384 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.