Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210874

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QTERNMET XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
2.5MG;1GM;EQ 2.5MG BASE
Marketing Status: Discontinued
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERNMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG;1GM;EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210874
Product Number: 001
Approval Date: May 2, 2019
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Discontinued
Patent and Exclusivity Information
QTERNMET XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
5MG;1GM;EQ 2.5MG BASE
Marketing Status: Discontinued
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERNMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;1GM;EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210874
Product Number: 002
Approval Date: May 2, 2019
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Discontinued
Patent and Exclusivity Information
QTERNMET XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
5MG;1GM;EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERNMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;1GM;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210874
Product Number: 003
Approval Date: May 2, 2019
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Discontinued
Patent and Exclusivity Information
QTERNMET XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
10MG;1GM;EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: QTERNMET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;1GM;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210874
Product Number: 004
Approval Date: May 2, 2019
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Discontinued
Patent and Exclusivity Information

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