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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Boehringer Ingelheim
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Baxter
Cantor Fitzgerald
Dow
Deloitte
AstraZeneca
Harvard Business School

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076483

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NDA 076483 describes FOSINOPRIL SODIUM, which is a drug marketed by Apotex Inc, Actavis Labs Fl Inc, Invagen Pharms, Watson Labs, Teva, Aurobindo Pharma Ltd, Prinston Inc, Ranbaxy Labs Ltd, Upsher-smith Labs, Mylan, Emcure Pharms India, Sun Pharm Inds Ltd, Aurobindo Pharma, and Sandoz, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the FOSINOPRIL SODIUM profile page.

The generic ingredient in FOSINOPRIL SODIUM 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 076483

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

Pharmacology for NDA: 076483

Suppliers and Packaging for NDA: 076483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM
fosinopril sodium
TABLET;ORAL 076483 ANDA Eon Labs, Inc. 0185-0041 0185-0041-09 90 TABLET in 1 BOTTLE (0185-0041-09)
FOSINOPRIL SODIUM
fosinopril sodium
TABLET;ORAL 076483 ANDA Eon Labs, Inc. 0185-0041 0185-0041-10 1000 TABLET in 1 BOTTLE (0185-0041-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 23, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 23, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 23, 2004TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Fuji
Julphar
Citi
Harvard Business School
Deloitte
Farmers Insurance
Cantor Fitzgerald
US Army

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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