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Generated: April 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021286

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NDA 021286 describes BENICAR, which is a drug marketed by Daiichi Sankyo and is included in two NDAs. It is available from eight suppliers. 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. Fifteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
Summary for 021286
Tradename:BENICAR
Applicant:Daiichi Sankyo
Ingredient:olmesartan medoxomil
Patents:0
Formulation / Manufacturing:see details
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 A-S Medication Solutions 50090-0877 50090-0877-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-0877-0)
BENICAR olmesartan medoxomil TABLET;ORAL 021286 NDA Med-Health Pharma, LLC 51138-211 51138-211-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51138-211-30)

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
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-004 Apr 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-001 Apr 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Daiichi Sankyo BENICAR olmesartan medoxomil TABLET;ORAL 021286-003 Apr 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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