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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079237

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NDA 079237 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, Sciegen Pharms Inc, 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 nineteen drug master file entries for this compound. Additional details are available on the hydralazine hydrochloride; hydrochlorothiazide; reserpine profile page.

Summary for NDA: 079237

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

Pharmacology for NDA: 079237

Ingredient-typeThiazides
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 079237

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE
hydrochlorothiazide
CAPSULE;ORAL 079237 ANDA Blenheim Pharmacal, Inc. 10544-544 10544-544-90 90 CAPSULE in 1 BOTTLE (10544-544-90)
HYDROCHLOROTHIAZIDE
hydrochlorothiazide
CAPSULE;ORAL 079237 ANDA Heritage Pharmaceuticals Inc. 23155-045 23155-045-01 100 CAPSULE in 1 BOTTLE (23155-045-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength12.5MG
Approval Date:Apr 2, 2009TE:ABRLD:No


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Federal Trade Commission
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Dow
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US Department of Justice
Colorcon

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