Drug Approval Package
Carnitor (levocarnitine) Injection 200mg/mL
Company: Sigma-Tau Pharmaceuticals, Inc.
Application No.: 020182, S006
Approval Date: 12/15/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s) & Correspondence (PDF)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)