Drug application

OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE)

Drugs@FDA ANDA 205545 · AJANTA PHARMA LTD

Key facts

Drug name OMEPRAZOLE AND SODIUM BICARBONATE
Active ingredients OMEPRAZOLE, SODIUM BICARBONATE
Application type ANDA
Application number 205545
Company AJANTA PHARMA LTD
Dosage forms FOR SUSPENSION, ORAL
Strength 20MG/PACKET;1.68GM/PACKET
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 27, 2016

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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