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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091163

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NDA 091163 describes FOSINOPRIL SODIUM, which is a drug marketed by Actavis Labs Fl Inc, Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher-smith Labs, Watson Labs, Aurobindo Pharma, Emcure Pharms Ltd, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from fifteen 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 091163
Tradename:FOSINOPRIL SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:fosinopril sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091163
Medical Subject Heading (MeSH) Categories for 091163
Suppliers and Packaging for NDA: 091163
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 091163 ANDA Aurobindo Pharma Limited 65862-471 N 65862-471-30
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 091163 ANDA Aurobindo Pharma Limited 65862-471 N 65862-471-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 30, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Mar 30, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Mar 30, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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McKinsey
Healthtrust
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Chubb
Cipla
Julphar
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