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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022314

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EXFORGE HCT (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 5MG BASE;12.5MG;160MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: EXFORGE HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;12.5MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022314
Product Number: 001
Approval Date: Apr 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
EXFORGE HCT (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 5MG BASE;25MG;160MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: EXFORGE HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;25MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022314
Product Number: 002
Approval Date: Apr 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
EXFORGE HCT (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;12.5MG;160MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: EXFORGE HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;12.5MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022314
Product Number: 003
Approval Date: Apr 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
EXFORGE HCT (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;25MG;160MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: EXFORGE HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022314
Product Number: 004
Approval Date: Apr 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
EXFORGE HCT (AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)
EQ 10MG BASE;25MG;320MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Proprietary Name: EXFORGE HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;25MG;320MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022314
Product Number: 005
Approval Date: Apr 30, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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