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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087059

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NDA 087059 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Lannett Holdings Inc, Mylan, Prinston Inc, Sun Pharm Inds Inc, Unichem, Morton Grove, Roxane, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage Pharms Inc, Impax Labs, Inwood Labs, Lannett, Leading Pharma Llc, Mast Mm, Mylan Pharms Inc, Pvt Form, Sciegen Pharms Inc, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Yaopharma Co Ltd, and Pharmeral, and is included in one hundred and nine NDAs. It is available from seventy-three suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 087059
Applicant:Dava Pharms Inc
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087059
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 087059
Suppliers and Packaging for NDA: 087059
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 087059 ANDA ReadyMeds 64205-820 E 64205-820-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Queensland Health

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