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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Argus Health

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077833

« Back to Dashboard

NDA 077833 describes NADOLOL AND BENDROFLUMETHIAZIDE, which is a drug marketed by Impax Labs and Mylan and is included in two NDAs. It is available from one supplier. Additional details are available on the NADOLOL AND BENDROFLUMETHIAZIDE profile page.

The generic ingredient in NADOLOL AND BENDROFLUMETHIAZIDE is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 077833
Applicant:Impax Labs
Ingredient:bendroflumethiazide; nadolol
Formulation / Manufacturing:see details
Pharmacology for NDA: 077833
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 077833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 077833 ANDA Impax Generics 0115-5311 N 0115-5311-01
NADOLOL AND BENDROFLUMETHIAZIDE bendroflumethiazide; nadolol TABLET;ORAL 077833 ANDA Impax Generics 0115-5311 N 0115-5311-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;40MG
Approval Date:Mar 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;80MG
Approval Date:Mar 30, 2007TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Express Scripts
Chinese Patent Office

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.