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Details for New Drug Application (NDA): 020182

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NDA 020182 describes CARNITOR, which is a drug marketed by Sigma Tau 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. Six suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

Summary for NDA: 020182

Tradename:
CARNITOR
Applicant:
Sigma Tau
Ingredient:
levocarnitine
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 020182

Ingredient-typeCarnitine

Suppliers and Packaging for NDA: 020182

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARNITOR
levocarnitine
INJECTABLE;INJECTION 020182 NDA Sigma-Tau Pharmaceuticals, Inc. 54482-147 54482-147-01 5 VIAL in 1 CARTON (54482-147-01) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Dec 16, 1992TE:APRLD:Yes
Patent:6,335,369Patent Expiration:Jan 18, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
Patent:6,429,230Patent Expiration:Jan 18, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
Patent:6,696,493Patent Expiration:Jan 18, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS


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