Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200045

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AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE)
EQ 150MG BASE;EQ 5MG BASE;12.5MG
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Proprietary Name: AMTURNIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE;EQ 5MG BASE;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N200045
Product Number: 001
Approval Date: Dec 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;EQ 5MG BASE;12.5MG
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Proprietary Name: AMTURNIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 5MG BASE;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N200045
Product Number: 002
Approval Date: Dec 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;EQ 5MG BASE;25MG
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Proprietary Name: AMTURNIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 5MG BASE;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N200045
Product Number: 003
Approval Date: Dec 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;EQ 10MG BASE;12.5MG
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Proprietary Name: AMTURNIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 10MG BASE;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N200045
Product Number: 004
Approval Date: Dec 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information

AMTURNIDE (ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;EQ 10MG BASE;25MG
Marketing Status: Discontinued

Active Ingredient: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Proprietary Name: AMTURNIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;EQ 10MG BASE;25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N200045
Product Number: 005
Approval Date: Dec 21, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information