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Details for New Drug Application (NDA): 075861

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NDA 075861 describes LEVOCARNITINE, which is a drug marketed by Lyne, Corepharma, Luitpold, Eurohlth Intl Sarl, Teva Pharms Usa, and Hi Tech Pharma, and is included in six NDAs. It is available from five 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. Six suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for NDA: 075861

Formulation / Manufacturing:see details

Pharmacology for NDA: 075861


Suppliers and Packaging for NDA: 075861

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 075861 ANDA American Regent, Inc. 0517-1045 0517-1045-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-1045-25) > 5 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Jun 22, 2001TE:APRLD:No

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