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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 203018


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NDA 203018 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, Norvium Bioscience, 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, 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, Alkem Labs Ltd, and Pharmeral, and is included in one hundred and eleven NDAs. It is available from forty-five 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 203018
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Sciegen Pharms Inc
Ingredient:hydrochlorothiazide
Patents:0
Pharmacology for NDA: 203018
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 203018
Suppliers and Packaging for NDA: 203018
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 203018 ANDA ScieGen Pharmaceuticals, Inc. 50228-111 50228-111-10 1000 TABLET in 1 BOTTLE (50228-111-10)
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 203018 ANDA ScieGen Pharmaceuticals, Inc. 50228-111 50228-111-30 30 TABLET in 1 BOTTLE (50228-111-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jul 23, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jul 23, 2014TE:ABRLD:No

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