Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206073

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GLYXAMBI (EMPAGLIFLOZIN; LINAGLIPTIN)
10MG;5MG Marketing Status: Prescription

Active Ingredient: EMPAGLIFLOZIN; LINAGLIPTIN
Proprietary Name: GLYXAMBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206073
Product Number: 001
Approval Date: Jan 30, 2015
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Prescription
Patent and Exclusivity Information

GLYXAMBI (EMPAGLIFLOZIN; LINAGLIPTIN)
25MG;5MG Marketing Status: Prescription

Active Ingredient: EMPAGLIFLOZIN; LINAGLIPTIN
Proprietary Name: GLYXAMBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206073
Product Number: 002
Approval Date: Jan 30, 2015
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Prescription
Patent and Exclusivity Information

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