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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212138

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EMPAGLIFLOZIN (EMPAGLIFLOZIN)
10MG
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN
Proprietary Name: EMPAGLIFLOZIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A212138
Product Number: 001
Approval Date: Aug 3, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMPAGLIFLOZIN (EMPAGLIFLOZIN)
25MG
Marketing Status: Discontinued
Active Ingredient: EMPAGLIFLOZIN
Proprietary Name: EMPAGLIFLOZIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A212138
Product Number: 002
Approval Date: Aug 3, 2022
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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