Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Covington
Mallinckrodt
Federal Trade Commission
Cerilliant
Daiichi Sankyo
Baxter
Julphar

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084878

« Back to Dashboard

NDA 084878 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 sixty 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 084878
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Hikma Intl Pharms
Ingredient:hydrochlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 084878
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 084878
Suppliers and Packaging for NDA: 084878
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 084878 ANDA West-ward Pharmaceutical Corp 0143-1256 N 0143-1256-10
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 084878 ANDA West-ward Pharmaceutical Corp 0143-1256 N 0143-1256-51

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Jul 12, 2006TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Argus Health
QuintilesIMS
Colorcon
Fish and Richardson
Covington
Johnson and Johnson
Citi
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.