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Cerilliant
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US Department of Justice
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QuintilesIMS
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205670

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NDA 205670 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 205670
Tradename:FOSINOPRIL SODIUM
Applicant:Prinston Inc
Ingredient:fosinopril sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205670
Medical Subject Heading (MeSH) Categories for 205670
Suppliers and Packaging for NDA: 205670
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 205670 ANDA Solco Healthcare LLC 43547-386 N 43547-386-09
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 205670 ANDA Solco Healthcare LLC 43547-386 N 43547-386-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 29, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 29, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 29, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Deloitte
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Fish and Richardson
Medtronic
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