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Serving leading biopharmaceutical companies globally:

Baxter
Deloitte
UBS
Accenture
Cantor Fitzgerald
Farmers Insurance
Teva
Fuji
Novartis
US Army

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200645

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NDA 200645 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-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 200645
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Alembic Pharms Ltd
Ingredient:hydrochlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 200645
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 200645
Suppliers and Packaging for NDA: 200645
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide CAPSULE;ORAL 200645 ANDA Alembic Pharmaceuticals Limited 46708-438 N 46708-438-10
HYDROCHLOROTHIAZIDE hydrochlorothiazide CAPSULE;ORAL 200645 ANDA Alembic Pharmaceuticals Limited 46708-438 N 46708-438-91

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength12.5MG
Approval Date:Nov 30, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Baxter
Daiichi Sankyo
McKesson
Federal Trade Commission
Argus Health
Merck
US Army

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