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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091662

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NDA 091662 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 Co 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, 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-five 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 091662
Tradename:HYDROCHLOROTHIAZIDE
Applicant:Lannett Co Inc
Ingredient:hydrochlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091662
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 091662
Suppliers and Packaging for NDA: 091662
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide CAPSULE;ORAL 091662 ANDA Lannett Company, Inc. 0527-1635 N 0527-1635-01
HYDROCHLOROTHIAZIDE hydrochlorothiazide CAPSULE;ORAL 091662 ANDA Lannett Company, Inc. 0527-1635 N 0527-1635-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength12.5MG
Approval Date:Jan 27, 2012TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
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