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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021437


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NDA 021437 describes INSPRA, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the INSPRA profile page.

The generic ingredient in INSPRA is eplerenone. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
Summary for 021437
Tradename:INSPRA
Applicant:Upjohn
Ingredient:eplerenone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021437
Mechanism of ActionAldosterone Antagonists
Suppliers and Packaging for NDA: 021437
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INSPRA eplerenone TABLET;ORAL 021437 NDA Pfizer Laboratories Div Pfizer Inc 0025-1710 0025-1710-01 30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01)
INSPRA eplerenone TABLET;ORAL 021437 NDA Pfizer Laboratories Div Pfizer Inc 0025-1720 0025-1720-03 30 TABLET, FILM COATED in 1 BOTTLE (0025-1720-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 27, 2002TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Sep 27, 2002TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Sep 27, 2002TE:RLD:No

Expired US Patents for NDA 021437

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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