Drug application

EZETIMIBE AND SIMVASTATIN (EZETIMIBE, SIMVASTATIN)

Drugs@FDA ANDA 200909 · DR REDDYS LABS SA

Key facts

Drug name EZETIMIBE AND SIMVASTATIN
Active ingredients EZETIMIBE, SIMVASTATIN
Application type ANDA
Application number 200909
Company DR REDDYS LABS SA
Dosage forms TABLET, ORAL
Strength 10MG;10MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission class Not Applicable
Latest submission status date Apr 26, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

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

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