Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022426

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OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 12.5MG BASE;EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022426
Product Number: 005
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 25MG BASE;EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022426
Product Number: 001
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 25MG BASE;EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE;EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022426
Product Number: 002
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 25MG BASE;EQ 45MG BASE
Marketing Status: Prescription

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE;EQ 45MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022426
Product Number: 003
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022426
Product Number: 004
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

OSENI (ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE)
EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: OSENI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022426
Product Number: 006
Approval Date: Jan 25, 2013
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information