Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 012151

Expand all

ALDACTONE (SPIRONOLACTONE)
25MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: ALDACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N012151
Product Number: 009
Approval Date: Dec 30, 1983
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALDACTONE (SPIRONOLACTONE)
50MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: ALDACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N012151
Product Number: 008
Approval Date: Dec 30, 1982
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALDACTONE (SPIRONOLACTONE)
100MG
Marketing Status: Prescription

Active Ingredient: SPIRONOLACTONE
Proprietary Name: ALDACTONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N012151
Product Number: 010
Approval Date: Dec 30, 1983
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information