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Details for New Drug Application (NDA): 203414

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NDA 203414 describes KAZANO, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are seventeen patents protecting this drug. Additional details are available on the KAZANO profile page.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

Summary for NDA: 203414

Tradename:
KAZANO
Applicant:
Takeda Pharms Usa
Ingredient:
alogliptin benzoate; metformin hydrochloride
Patents:17
Formulation / Manufacturing:see details

Pharmacology for NDA: 203414

Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors

Suppliers and Packaging for NDA: 203414

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL 203414 NDA Perrigo New York Inc 45802-169 45802-169-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72)
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL 203414 NDA Perrigo New York Inc 45802-211 45802-211-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;500MG
Approval Date:Jan 25, 2013TE:RLD:No
Patent:8,288,539Patent Expiration:Mar 15, 2025Product Flag?Substance Flag?YDelist Request?
Patent:8,900,638Patent Expiration:May 24, 2029Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING EXAMINE, A TRIAL EVALUATING CARDIOVASCULAR ISCHEMIC RISKS ASSOCIATED WITH ALOGLIPTIN USE IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK OF ISCHEMIC CARDIOVASCULAR DISEASE

Expired Orange Book Patents for NDA: 203414

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20136,166,042► subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20135,965,584► subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20136,329,404► subscribe
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