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Last Updated: May 6, 2021

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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. It is available from two suppliers. 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. Fifty-one 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
Pharmacology for NDA: 020386
Medical Subject Heading (MeSH) Categories for 020386
Suppliers and Packaging for NDA: 020386
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COZAAR losartan potassium TABLET;ORAL 020386 NDA Merck Sharp & Dohme Corp. 0006-0951 0006-0951-54 90 TABLET, FILM COATED in 1 BOTTLE (0006-0951-54)
COZAAR losartan potassium TABLET;ORAL 020386 NDA Merck Sharp & Dohme Corp. 0006-0952 0006-0952-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0952-31)
Paragraph IV (Patent) Challenges for 020386
Tradename Dosage Ingredient NDA Submissiondate
COZAAR TABLET;ORAL losartan potassium 020386

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Apr 14, 1995TE:RLD: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 020386-003 Oct 13, 1998   Get Started for $10   Get Started for $10
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995   Get Started for $10   Get Started for $10
Organon COZAAR losartan potassium TABLET;ORAL 020386-003 Oct 13, 1998   Get Started for $10   Get Started for $10
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995   Get Started for $10   Get Started for $10
Organon COZAAR losartan potassium TABLET;ORAL 020386-001 Apr 14, 1995   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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