Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203414

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KAZANO (ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE)
EQ 12.5MG BASE;500MG Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Proprietary Name: KAZANO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203414
Product Number: 001
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KAZANO (ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE)
EQ 12.5MG BASE;1GM Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Proprietary Name: KAZANO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203414
Product Number: 002
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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