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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 040810


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NDA 040810 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Mylan, Prinston Inc, Sciegen Pharms 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, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan Pharms Inc, Oxford Pharms, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, 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 ten NDAs. It is available from forty-six suppliers. Additional details are available on the HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in HYDROCHLOROTHIAZIDE is hydralazine hydrochloride; hydrochlorothiazide; reserpine. There are twenty-one drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.
Summary for 040810
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Sun Pharm Inds Inc
Ingredient:hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040810

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Mar 27, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Mar 27, 2007TE:RLD:No

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