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PRILOSEC OTC (nda021229)- (EQ 20MG BASE)

OMEPRAZOLE MAGNESIUM ASTRAZENECA
EQ 20MG BASE
Yes No
2019-Nov-15 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
3 0 3
Total Other Developers 5
Drugs with Suitability Yes
EQ 20MG BASE ** ** - - 2
NDA Sales Available Total Generic Sales Available
Yes 2
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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