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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090011

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AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;160MG
Marketing Status: Prescription
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: AB
Application Number: A090011
Product Number: 001
Approval Date: Mar 28, 2013
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;320MG
Marketing Status: Prescription
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: AB
Application Number: A090011
Product Number: 003
Approval Date: Mar 28, 2013
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;160MG
Marketing Status: Prescription
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: AB
Application Number: A090011
Product Number: 002
Approval Date: Mar 28, 2013
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
AMLODIPINE BESYLATE AND VALSARTAN (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;320MG
Marketing Status: Prescription
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: AB
Application Number: A090011
Product Number: 004
Approval Date: Mar 28, 2013
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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