Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020387

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HYZAAR (HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM)
12.5MG;50MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: HYZAAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020387
Product Number: 001
Approval Date: Apr 28, 1995
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

HYZAAR (HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM)
12.5MG;100MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: HYZAAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020387
Product Number: 003
Approval Date: Oct 20, 2005
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information

HYZAAR (HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM)
25MG;100MG
Marketing Status: Prescription

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: HYZAAR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020387
Product Number: 002
Approval Date: Nov 10, 1998
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information