Orange Book product

LEVOXYL 0.3MG **Federal Register determination that product was not…

Orange Book NDA 021301 · KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC · Discontinued

Key facts

Proprietary name LEVOXYL
Active ingredients LEVOTHYROXINE SODIUM
Strength 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form TABLET
Route ORAL
Application NDA021301
Applicant holder KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 25, 2001

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 10–99 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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