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NEXIUM (nda021153)- (EQ 20MG BASE,EQ 40MG BASE)

ESOMEPRAZOLE MAGNESIUM ASTRAZENECA
EQ 20MG BASE,EQ 40MG BASE
Yes No
2020-May-03 Expired
None None
None No
NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. • Maintenance of healing of EE in adults. • Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. • Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. • Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. • Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.
21 0 18
Total Other Developers None
Drugs with Suitability No
EQ 20MG BASE ** ** - - 13
EQ 40MG BASE ** ** Down - 14
NDA Sales Available Total Generic Sales Available
Yes 14
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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