Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200175

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TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
EQ 5MG BASE;12.5MG;20MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: TRIBENZOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200175
Product Number: 001
Approval Date: Jul 23, 2010
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
EQ 5MG BASE;12.5MG;40MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: TRIBENZOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200175
Product Number: 002
Approval Date: Jul 23, 2010
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
EQ 5MG BASE;25MG;40MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: TRIBENZOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;25MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200175
Product Number: 003
Approval Date: Jul 23, 2010
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
EQ 10MG BASE;12.5MG;40MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: TRIBENZOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;12.5MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N200175
Product Number: 004
Approval Date: Jul 23, 2010
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRIBENZOR (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
EQ 10MG BASE;25MG;40MG
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: TRIBENZOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N200175
Product Number: 005
Approval Date: Jul 23, 2010
Applicant Holder Full Name: COSETTE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information