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

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 021286

Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 25, 2002	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 25, 2002	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Apr 25, 2002	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021286

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

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