Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021437

Expand all

INSPRA (EPLERENONE)
25MG
Marketing Status: Prescription

Active Ingredient: EPLERENONE
Proprietary Name: INSPRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021437
Product Number: 001
Approval Date: Sep 27, 2002
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

INSPRA (EPLERENONE)
50MG
Marketing Status: Prescription

Active Ingredient: EPLERENONE
Proprietary Name: INSPRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021437
Product Number: 002
Approval Date: Sep 27, 2002
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

INSPRA (EPLERENONE)
100MG
Marketing Status: Discontinued

Active Ingredient: EPLERENONE
Proprietary Name: INSPRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021437
Product Number: 003
Approval Date: Sep 27, 2002
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information