Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200678

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KOMBIGLYZE XR (METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
500MG;EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: KOMBIGLYZE XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200678
Product Number: 001
Approval Date: Nov 5, 2010
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

KOMBIGLYZE XR (METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
1GM;EQ 2.5MG BASE
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: KOMBIGLYZE XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200678
Product Number: 003
Approval Date: Nov 5, 2010
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

KOMBIGLYZE XR (METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE)
1GM;EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Proprietary Name: KOMBIGLYZE XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N200678
Product Number: 002
Approval Date: Nov 5, 2010
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information