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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Boehringer Ingelheim
Teva
Farmers Insurance
Merck
Healthtrust
Accenture
Deloitte
Colorcon

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008303

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NDA 008303 describes APRESOLINE, which is a drug marketed by Novartis and is included in two NDAs. Additional details are available on the APRESOLINE profile page.

The generic ingredient in APRESOLINE is hydralazine hydrochloride; hydrochlorothiazide. There are twenty drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide profile page.

Summary for 008303

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

Novartis
Cantor Fitzgerald
Citi
Queensland Health
Merck
McKinsey
Baxter
UBS
Mallinckrodt
Cipla

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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