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Product Details for ANDA 202491

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

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202491
Product Number: 001
Approval Date: Nov 3, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202491
Product Number: 002
Approval Date: Nov 3, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;25MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202491
Product Number: 003
Approval Date: Nov 3, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202491
Product Number: 004
Approval Date: Nov 3, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202491
Product Number: 005
Approval Date: Nov 3, 2016
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information