Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Colorcon
Boehringer Ingelheim
Accenture
Medtronic
US Army
Cerilliant
US Department of Justice
Fish and Richardson

Generated: July 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021956

« Back to Dashboard

NDA 021956 describes DUTOPROL, which is a drug marketed by Concordia Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DUTOPROL profile page.

The generic ingredient in DUTOPROL is hydrochlorothiazide; metoprolol succinate. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol succinate profile page.
Summary for 021956
Tradename:DUTOPROL
Applicant:Concordia Pharms Inc
Ingredient:hydrochlorothiazide; metoprolol succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021956
Ingredient-typeThiazides
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 021956
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DUTOPROL hydrochlorothiazide; metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 021956 NDA Concordia Pharmaceuticals Inc. 59212-087 N 59212-087-30
DUTOPROL hydrochlorothiazide; metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 021956 NDA Concordia Pharmaceuticals Inc. 59212-095 N 59212-095-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG;EQ 25MG TARTRATE
Approval Date:Aug 28, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG;EQ 50MG TARTRATE
Approval Date:Aug 28, 2006TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG;EQ 100MG TARTRATE
Approval Date:Aug 28, 2006TE:RLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cipla
Chubb
Argus Health
Medtronic
Covington
UBS
Queensland Health
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.