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YOSPRALA (nda205103)- (81MG;40MG,325MG;40MG)

ASPIRIN; OMEPRAZOLE GENUS LIFESCIENCES
81MG;40MG,325MG;40MG
Yes Yes
2033-Mar-13 Expired
None None
None No
YOSPRALA is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. The aspirin component of YOSPRALA is indicated for: • reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, • reducing the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, • reducing the combined risk of MI and sudden death in patients with chronic stable angina pectoris, • use in patients who have undergone revascularization procedures (Coronary Artery Bypass Graft [CABG] or Percutaneous Transluminal Coronary Angioplasty [PTCA]) when there is a pre-existing condition for which aspirin is already indicated. The omeprazole component of YOSPRALA is indicated for decreasing the risk of developing aspirin associated gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers.
0 1 0
Total Other Developers 1
Drugs with Suitability No
81MG;40MG ** ** - - -
325MG;40MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
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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