Product Details for ANDA 203253
SPIRONOLACTONE (SPIRONOLACTONE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
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: A203253
Product Number: 001
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
SPIRONOLACTONE (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: A203253
Product Number: 001
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203253
Product Number: 002
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
SPIRONOLACTONE (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: A203253
Product Number: 002
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A203253
Product Number: 003
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: SPIRONOLACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203253
Product Number: 003
Approval Date: Apr 23, 2014
Applicant Holder Full Name: JUBILANT GENERICS LTD
Marketing Status: Prescription
Patent and Exclusivity Information