Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022545

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TEKAMLO (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE)
EQ 150MG BASE;EQ 5MG BASE
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Proprietary Name: TEKAMLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE;EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022545
Product Number: 001
Approval Date: Aug 26, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEKAMLO (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE)
EQ 150MG BASE;EQ 10MG BASE
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Proprietary Name: TEKAMLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE;EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022545
Product Number: 002
Approval Date: Aug 26, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEKAMLO (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE)
EQ 300MG BASE;EQ 5MG BASE
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Proprietary Name: TEKAMLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022545
Product Number: 003
Approval Date: Aug 26, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

TEKAMLO (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE)
EQ 300MG BASE;EQ 10MG BASE
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
Proprietary Name: TEKAMLO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022545
Product Number: 004
Approval Date: Aug 26, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information