Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209091

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QTERN (DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE)
5MG;EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209091
Product Number: 002
Approval Date: May 2, 2019
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
QTERN (DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE)
10MG;EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209091
Product Number: 001
Approval Date: Feb 27, 2017
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

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