Drug application
OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE)
Drugs@FDA ANDA 204923 · AUROBINDO PHARMA
Key facts
| Drug name | OMEPRAZOLE AND SODIUM BICARBONATE |
|---|---|
| Active ingredients | OMEPRAZOLE, SODIUM BICARBONATE |
| Application type | ANDA |
| Application number | 204923 |
| Company | AUROBINDO PHARMA |
| Dosage forms | CAPSULE, ORAL |
| Strength | 20MG;1.1GM |
| Marketing status | Over-the-counter |
| Reference listed drug | No |
| Latest submission status date | Nov 7, 2016 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- None 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.