Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078245

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

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078245
Product Number: 001
Approval Date: Oct 6, 2010
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078245
Product Number: 002
Approval Date: May 21, 2010
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078245
Product Number: 003
Approval Date: Oct 6, 2010
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information