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Last Updated: October 12, 2024

Details for New Drug Application (NDA): 021286


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NDA 021286 describes BENICAR, which is a drug marketed by Cosette and is included in two NDAs. It is available from one supplier. Additional details are available on the BENICAR profile page.

The generic ingredient in BENICAR is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 021286
Tradename:BENICAR
Applicant:Cosette
Ingredient:olmesartan medoxomil
Patents:0
Pharmacology for NDA: 021286
Medical Subject Heading (MeSH) Categories for 021286
Suppliers and Packaging for NDA: 021286
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENICAR olmesartan medoxomil TABLET;ORAL 021286 NDA Cosette Pharmaceuticals, Inc. 0713-0860 0713-0860-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0860-30)
BENICAR olmesartan medoxomil TABLET;ORAL 021286 NDA Cosette Pharmaceuticals, Inc. 0713-0861 0713-0861-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0861-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 25, 2002TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 25, 2002TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 25, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021286

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
Cosette BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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