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Last Updated: May 24, 2022

Details for New Drug Application (NDA): 020386


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NDA 020386 describes COZAAR, which is a drug marketed by Organon and is included in one NDA. Additional details are available on the COZAAR profile page.

The generic ingredient in COZAAR is losartan potassium. There are thirty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the losartan potassium profile page.
Summary for 020386
Tradename:COZAAR
Applicant:Organon
Ingredient:losartan potassium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020386

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 14, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 14, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 13, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020386

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon COZAAR losartan potassium TABLET;ORAL 020386-002 Apr 14, 1995 See Plans and Pricing See Plans and Pricing
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995 See Plans and Pricing See Plans and Pricing
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995 See Plans and Pricing See Plans and Pricing
Organon COZAAR losartan potassium TABLET;ORAL 020386-002 Apr 14, 1995 See Plans and Pricing See Plans and Pricing
Organon COZAAR losartan potassium TABLET;ORAL 020386-003 Oct 13, 1998 See Plans and Pricing See Plans and Pricing
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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