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Generated: November 17, 2018

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Details for New Drug Application (NDA): 018948

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NDA 018948 describes CARNITOR, which is a drug marketed by Leadiant Biosci Inc and is included in three NDAs. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the CARNITOR profile page.

The generic ingredient in CARNITOR 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 018948
Tradename:CARNITOR
Applicant:Leadiant Biosci Inc
Ingredient:levocarnitine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018948
Ingredient-typeCarnitine
Suppliers and Packaging for NDA: 018948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARNITOR levocarnitine SOLUTION;ORAL 018948 NDA Hi-Tech Pharmacal Co., Inc. 50383-172 50383-172-90 9 BLISTER PACK in 1 CARTON (50383-172-90) > 10 TABLET in 1 BLISTER PACK
CARNITOR levocarnitine SOLUTION;ORAL 018948 NDA Leadiant Biosciences, Inc. 54482-144 54482-144-07 10 BLISTER PACK in 1 CARTON (54482-144-07) > 9 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength330MG
Approval Date:Dec 27, 1985TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1GM/10ML
Approval Date:Apr 27, 1988TE:RLD:No

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