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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212533


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NDA 212533 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 212533
Tradename:LEVOCARNITINE
Applicant:Sciegen Pharms Inc
Ingredient:levocarnitine
Patents:0
Pharmacology for NDA: 212533
Suppliers and Packaging for NDA: 212533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVOCARNITINE levocarnitine SOLUTION;ORAL 212533 ANDA TRUPHARMA, LLC 52817-830 52817-830-04 118 mL in 1 BOTTLE (52817-830-04)
LEVOCARNITINE levocarnitine SOLUTION;ORAL 212533 ANDA Saptalis Pharmaceuticals, LLC 71656-016 71656-016-01 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1GM/10ML
Approval Date:Nov 10, 2021TE:AARLD:No

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