Drug application

LEVOXYL (LEVOTHYROXINE SODIUM)

Drugs@FDA NDA 021301 · KING PHARMS

Key facts

Drug name LEVOXYL
Active ingredients LEVOTHYROXINE SODIUM
Application type NDA
Application number 021301
Company KING PHARMS
Dosage forms TABLET, ORAL
Strength 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Marketing status Prescription
TE codes AB1, AB3
Reference listed drug Yes
Latest submission class Type 5 - New Formulation or New Manufacturer
Latest submission status date May 25, 2001

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 10–99 Products
  • 10–99 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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