Orange Book product

CARNITOR SF 1GM/10ML

Orange Book NDA 019257 · LEADIANT BIOSCIENCES INC · Prescription

Key facts

Proprietary name CARNITOR SF
Active ingredients LEVOCARNITINE
Strength 1GM/10ML
Dosage form SOLUTION
Route ORAL
Application NDA019257
Applicant holder LEADIANT BIOSCIENCES INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Mar 28, 2007

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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