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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091235

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AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;160MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE AND VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091235
Product Number: 001
Approval Date: Mar 30, 2015
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;320MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE AND VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091235
Product Number: 003
Approval Date: Mar 30, 2015
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;160MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE AND VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;160MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091235
Product Number: 002
Approval Date: Mar 30, 2015
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;320MG
Marketing Status: Discontinued
Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: AMLODIPINE BESYLATE AND VALSARTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;320MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091235
Product Number: 004
Approval Date: Mar 30, 2015
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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