Drug application

OMEPRAZOLE (OMEPRAZOLE)

Drugs@FDA ANDA 078490 · DR REDDYS LABS LTD

Key facts

Drug name OMEPRAZOLE
Active ingredients OMEPRAZOLE
Application type ANDA
Application number 078490
Company DR REDDYS LABS LTD
Dosage forms CAPSULE, DELAYED REL PELLETS, ORAL
Strength 40MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Apr 17, 2009

At a glance

  • 1–9 Submissions
  • 10–99 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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