Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 208026

JENTADUETO XR (LINAGLIPTIN; METFORMIN HYDROCHLORIDE)
2.5MG;1GM
Marketing Status: Prescription

Active Ingredient: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Proprietary Name: JENTADUETO 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: N208026
Product Number: 001
Approval Date: May 27, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information

JENTADUETO XR (LINAGLIPTIN; METFORMIN HYDROCHLORIDE)
5MG;1GM
Marketing Status: Prescription

Active Ingredient: LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Proprietary Name: JENTADUETO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208026
Product Number: 002
Approval Date: May 27, 2016
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information