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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205103

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YOSPRALA (ASPIRIN; OMEPRAZOLE)
81MG;40MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; OMEPRAZOLE
Proprietary Name: YOSPRALA
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 81MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205103
Product Number: 001
Approval Date: Sep 14, 2016
Applicant Holder Full Name: GENUS LIFE SCIENCES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
YOSPRALA (ASPIRIN; OMEPRAZOLE)
325MG;40MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; OMEPRAZOLE
Proprietary Name: YOSPRALA
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 325MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205103
Product Number: 002
Approval Date: Sep 14, 2016
Applicant Holder Full Name: GENUS LIFE SCIENCES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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