You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215666


✉ Email this page to a colleague

« Back to Dashboard


NDA 215666 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva, Unichem, and Watson Labs Teva, and is included in thirteen NDAs. It is available from eleven suppliers. Additional details are available on the BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 215666
Pharmacology for NDA: 215666
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 215666
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 215666 ANDA Zydus Lifesciences Limited 70771-1760 70771-1760-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1760-1)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 215666 ANDA Zydus Lifesciences Limited 70771-1760 70771-1760-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1760-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;6.25MG
Approval Date:Nov 4, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Nov 4, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;6.25MG
Approval Date:Nov 4, 2022TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.