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PRILOSEC (nda019810)- (10MG,20MG,40MG)

OMEPRAZOLE ASTRAZENECA
10MG,20MG,40MG
Yes No
2019-May-10 Expired
None None
None No
PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 month of age and older • Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older • Pathologic hypersecretory conditions in adults
15 1 11
Total Other Developers None
Drugs with Suitability No
10MG ** ** - - 7
20MG ** ** - - 8
40MG ** ** - - 7
NDA Sales Available Total Generic Sales Available
No 8
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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