Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021437

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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: GD SEARLE 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: GD SEARLE 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: GD SEARLE LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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