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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201281

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JENTADUETO (LINAGLIPTIN; METFORMIN HYDROCHLORIDE)
2.5MG;500MG
Marketing Status: Prescription
Active Ingredient: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Proprietary Name: JENTADUETO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N201281
Product Number: 001
Approval Date: Jan 30, 2012
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
JENTADUETO (LINAGLIPTIN; METFORMIN HYDROCHLORIDE)
2.5MG;850MG
Marketing Status: Prescription
Active Ingredient: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Proprietary Name: JENTADUETO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;850MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N201281
Product Number: 002
Approval Date: Jan 30, 2012
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
JENTADUETO (LINAGLIPTIN; METFORMIN HYDROCHLORIDE)
2.5MG;1GM
Marketing Status: Prescription
Active Ingredient: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Proprietary Name: JENTADUETO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N201281
Product Number: 003
Approval Date: Jan 30, 2012
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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