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Federal Trade Commission
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076851

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NDA 076851 describes LEVOCARNITINE, which is a drug marketed by Luitpold, Teva Pharms Usa, West-ward Pharms Int, Hi Tech Pharma, Lyne, and Rising Pharms Inc, and is included in six NDAs. It is available from two 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. Four suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
Summary for 076851
Tradename:LEVOCARNITINE
Applicant:Lyne
Ingredient:levocarnitine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076851
Ingredient-typeCarnitine
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 Pharmaceuticals, Inc. 64980-503 N 64980-503-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1GM/10ML
Approval Date:Aug 10, 2004TE:AARLD:No

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