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Serving leading biopharmaceutical companies globally:

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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 087068

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NDA 087068 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, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tech Organized, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, and Pharmeral, and is included in one hundred and nine NDAs. It is available from seventy-four 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 087068
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Dava Pharms Inc
Ingredient:hydrochlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 087068
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 087068
Suppliers and Packaging for NDA: 087068
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 087068 ANDA ReadyMeds 64205-821 64205-821-30 30 TABLET in 1 BOTTLE (64205-821-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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