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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076139

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NDA 076139 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 India, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from seventeen 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 076139

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076139

Suppliers and Packaging for NDA: 076139

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076139 ANDA Teva Pharmaceuticals USA, Inc. 0093-7222 0093-7222-10 1000 TABLET in 1 BOTTLE (0093-7222-10)
FOSINOPRIL SODIUM fosinopril sodium TABLET;ORAL 076139 ANDA Teva Pharmaceuticals USA, Inc. 0093-7222 0093-7222-98 90 TABLET in 1 BOTTLE (0093-7222-98)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 25, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 25, 2003TE:ABRLD:No


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