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Serving leading biopharmaceutical companies globally:

McKesson
US Army
UBS
US Department of Justice
Harvard Business School
Accenture
Cantor Fitzgerald
Argus Health
Citi
Johnson and Johnson

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203018

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NDA 203018 describes HYDROCHLOROTHIAZIDE, which is a drug marketed by Leading Pharma Llc, Watson Labs, Roxane, Ivax Sub Teva Pharms, Prinston Inc, Actavis Elizabeth, Impax Labs, Ipca Labs Ltd, Unichem, Jubilant Cadista, Whiteworth Town Plsn, Sun Pharm Inds Inc, Vangard, Mylan, Sandoz, Tech Organized, Aurolife Pharma Llc, Solvay, Teva, Lannett, Superpharm, Usl Pharma, Watson Labs Teva, Heather, Mylan Pharms Inc, Ascot, Alembic Pharms Ltd, Elkins Sinn, Alra, Accord Hlthcare, Dava Pharms Inc, Morton Grove, Lannett Holdings Inc, Aurobindo Pharma, Tg United Labs, Inwood Labs, Barr, Abc Holding, Sun Pharm Inds, Apotex, Hikma Intl Pharms, Heritage Pharms Inc, Warner Chilcott, Mast Mm, Pvt Form, West Ward, 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 NDA: 203018

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203018

Ingredient-typeThiazides
Physiological EffectIncreased Diuresis

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 Vensun Pharmaceuticals, Inc. 42543-710 42543-710-01 100 TABLET in 1 BOTTLE (42543-710-01)
HYDROCHLOROTHIAZIDE
hydrochlorothiazide
TABLET;ORAL 203018 ANDA Vensun Pharmaceuticals, Inc. 42543-710 42543-710-05 500 TABLET in 1 BOTTLE (42543-710-05)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Express Scripts
Covington
Johnson and Johnson
Cantor Fitzgerald
Cipla
Boehringer Ingelheim
Fish and Richardson
Teva

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