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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202293

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FARXIGA (DAPAGLIFLOZIN)
5MG
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN
Proprietary Name: FARXIGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202293
Product Number: 001
Approval Date: Jan 8, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
FARXIGA (DAPAGLIFLOZIN)
10MG
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN
Proprietary Name: FARXIGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202293
Product Number: 002
Approval Date: Jan 8, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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