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Baxter
Novartis
Daiichi Sankyo
Fuji
Harvard Business School
McKinsey
Accenture
Covington
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Dow

Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019915

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NDA 019915 describes MONOPRIL, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. Additional details are available on the MONOPRIL profile page.

The generic ingredient in MONOPRIL is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for NDA: 019915

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

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 16, 1991TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 16, 1991TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 28, 1995TE:RLD:Yes

Expired Orange Book Patents for NDA: 019915

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
MONOPRIL
fosinopril sodium
TABLET;ORAL019915-003May 16, 19914,384,123► Subscribe
Bristol Myers Squibb
MONOPRIL
fosinopril sodium
TABLET;ORAL019915-003May 16, 19915,006,344*PED► Subscribe
Bristol Myers Squibb
MONOPRIL
fosinopril sodium
TABLET;ORAL019915-002May 16, 19914,337,201*PED► Subscribe
Bristol Myers Squibb
MONOPRIL
fosinopril sodium
TABLET;ORAL019915-004Mar 28, 19954,337,201*PED► Subscribe
Bristol Myers Squibb
MONOPRIL
fosinopril sodium
TABLET;ORAL019915-002May 16, 19915,006,344*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Moodys
Johnson and Johnson
Cantor Fitzgerald
Baxter
Queensland Health
UBS
US Army
Colorcon

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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