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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 076906

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NDA 076906 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, Ani Pharms Inc, Aurobindo Pharma, Emcure Pharms Ltd, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from nine 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. Four suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 076906
Tradename:FOSINOPRIL SODIUM
Applicant:Apotex Inc
Ingredient:fosinopril sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076906

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 17, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 17, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:May 17, 2005TE:ABRLD:No

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