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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021532


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NDA 021532 describes BENICAR HCT, which is a drug marketed by Cosette and is included in one NDA. It is available from two suppliers. Additional details are available on the BENICAR HCT profile page.

The generic ingredient in BENICAR HCT 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 021532
Tradename:BENICAR HCT
Applicant:Cosette
Ingredient:hydrochlorothiazide; olmesartan medoxomil
Patents:0
Pharmacology for NDA: 021532
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 021532
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532 NDA Cosette Pharmaceuticals, Inc. 0713-0863 0713-0863-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0863-30)
BENICAR HCT hydrochlorothiazide; olmesartan medoxomil TABLET;ORAL 021532 NDA Cosette Pharmaceuticals, Inc. 0713-0864 0713-0864-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0864-30)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;20MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;40MG
Approval Date:Jun 5, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021532

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