Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078243

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LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
25MG
Marketing Status: Prescription

Active Ingredient: LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078243
Product Number: 001
Approval Date: Oct 6, 2010
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
50MG
Marketing Status: Prescription

Active Ingredient: LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078243
Product Number: 002
Approval Date: Oct 6, 2010
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
100MG
Marketing Status: Prescription

Active Ingredient: LOSARTAN POTASSIUM
Proprietary Name: LOSARTAN POTASSIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078243
Product Number: 003
Approval Date: Oct 6, 2010
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information