Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022271

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NESINA (ALOGLIPTIN BENZOATE)
EQ 6.25MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE
Proprietary Name: NESINA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 6.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022271
Product Number: 001
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NESINA (ALOGLIPTIN BENZOATE)
EQ 12.5MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE
Proprietary Name: NESINA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022271
Product Number: 002
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NESINA (ALOGLIPTIN BENZOATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE
Proprietary Name: NESINA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022271
Product Number: 003
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information