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BioPharmaceutical Business Intelligence

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  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Novartis
Healthtrust
Cantor Fitzgerald
Citi
Accenture
Dow
Farmers Insurance
Teva
Cipla
McKesson

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078635

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NDA 078635 describes BISOPROLOL FUMARATE, which is a drug marketed by Anda Repository, Aurobindo Pharma, Mylan, Orit Labs Llc, Sandoz, Teva Pharms, Unichem Pharms (usa), Actavis Elizabeth, Apothecon, Ivax Sub Teva Pharms, Teva, Unichem, and Watson Labs Teva, and is included in sixteen NDAs. It is available from thirteen suppliers. Additional details are available on the BISOPROLOL FUMARATE profile page.

The generic ingredient in BISOPROLOL FUMARATE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.

Summary for 078635

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078635

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 078635

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 078635 ANDA Rebel Distributors Corp 21695-667 21695-667-30 30 TABLET in 1 BOTTLE, PLASTIC (21695-667-30)
BISOPROLOL FUMARATE bisoprolol fumarate TABLET;ORAL 078635 ANDA Rebel Distributors Corp 21695-667 21695-667-90 90 TABLET in 1 BOTTLE, PLASTIC (21695-667-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 18, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 18, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
McKesson
Queensland Health
Citi
Daiichi Sankyo
Julphar
Dow
Cipla
Mallinckrodt

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.

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