Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202187

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SPIRONOLACTONE (SPIRONOLACTONE)
25MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: SPIRONOLACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202187
Product Number: 001
Approval Date: Mar 6, 2014
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SPIRONOLACTONE (SPIRONOLACTONE)
50MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: SPIRONOLACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202187
Product Number: 002
Approval Date: Mar 6, 2014
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SPIRONOLACTONE (SPIRONOLACTONE)
100MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: SPIRONOLACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202187
Product Number: 003
Approval Date: Mar 6, 2014
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information