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Last Updated: March 28, 2024

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, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Ani Pharms, Aurobindo Pharma, Avet Lifesciences, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from eight 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. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 076483
Tradename:FOSINOPRIL SODIUM
Applicant:Chartwell Rx
Ingredient:fosinopril sodium
Patents:0
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 Chartwell RX, LLC 62135-041 62135-041-90 90 TABLET in 1 BOTTLE (62135-041-90)
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076483 ANDA Chartwell RX, LLC 62135-042 62135-042-90 90 TABLET in 1 BOTTLE (62135-042-90)

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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