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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205649

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XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
2.5MG;1GM
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: XIGDUO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205649
Product Number: 005
Approval Date: Jul 28, 2017
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
5MG;500MG
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: XIGDUO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205649
Product Number: 001
Approval Date: Oct 29, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
5MG;1GM
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: XIGDUO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205649
Product Number: 002
Approval Date: Oct 29, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
10MG;500MG
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: XIGDUO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205649
Product Number: 003
Approval Date: Oct 29, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
XIGDUO XR (DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE)
10MG;1GM
Marketing Status: Prescription
Active Ingredient: DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Proprietary Name: XIGDUO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205649
Product Number: 004
Approval Date: Oct 29, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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