Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022107

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TEKTURNA HCT (ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE)
EQ 150MG BASE;12.5MG Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: TEKTURNA HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE;12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022107
Product Number: 001
Approval Date: Jan 18, 2008
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEKTURNA HCT (ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE)
EQ 150MG BASE;25MG Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: TEKTURNA HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE;25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022107
Product Number: 002
Approval Date: Jan 18, 2008
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEKTURNA HCT (ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;12.5MG Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: TEKTURNA HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022107
Product Number: 003
Approval Date: Jan 18, 2008
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information

TEKTURNA HCT (ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE)
EQ 300MG BASE;25MG Marketing Status: Prescription

Active Ingredient: ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Proprietary Name: TEKTURNA HCT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE;25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022107
Product Number: 004
Approval Date: Jan 18, 2008
Applicant Holder Full Name: NODEN PHARMA DAC
Marketing Status:  Prescription
Patent and Exclusivity Information

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