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Generated: May 27, 2018

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 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 076483
Tradename:FOSINOPRIL SODIUM
Applicant:Upsher-smith Labs
Ingredient:fosinopril sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076483
Medical Subject Heading (MeSH) Categories for 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 N 0185-0041-09
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076483 ANDA Eon Labs, Inc. 0185-0041 N 0185-0041-10

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

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