Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 200435

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AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 5MG BASE;12.5MG;160MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200435
Product Number: 001
Approval Date: Sep 25, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 5MG BASE;25MG;160MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;25MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200435
Product Number: 002
Approval Date: Sep 25, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;12.5MG;160MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;12.5MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200435
Product Number: 005
Approval Date: Sep 25, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;25MG;160MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200435
Product Number: 003
Approval Date: Sep 25, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;25MG;320MG
Marketing Status: Discontinued

Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A200435
Product Number: 004
Approval Date: Sep 25, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information