Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021990

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EXFORGE (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;160MG Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: EXFORGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;160MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021990
Product Number: 002
Approval Date: Jun 20, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

EXFORGE (AMLODIPINE BESYLATE; VALSARTAN)
EQ 5MG BASE;320MG Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: EXFORGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;320MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021990
Product Number: 004
Approval Date: Jun 20, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

EXFORGE (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;160MG Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: EXFORGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;160MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021990
Product Number: 003
Approval Date: Jun 20, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

EXFORGE (AMLODIPINE BESYLATE; VALSARTAN)
EQ 10MG BASE;320MG Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; VALSARTAN
Proprietary Name: EXFORGE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;320MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021990
Product Number: 005
Approval Date: Jun 20, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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