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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040412

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NDA 040412 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, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tech Organized, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, 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 040412

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

Pharmacology for NDA: 040412

Ingredient-typeThiazides
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 040412

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 040412 ANDA Qualitest Pharmaceuticals 0603-3856 0603-3856-10 10 TABLET in 1 BOTTLE, PLASTIC (0603-3856-10)
HYDROCHLOROTHIAZIDE hydrochlorothiazide TABLET;ORAL 040412 ANDA Qualitest Pharmaceuticals 0603-3856 0603-3856-19 50 TABLET in 1 BOTTLE, PLASTIC (0603-3856-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 29, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 29, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Harvard Business School
Julphar
Daiichi Sankyo
Moodys
Queensland Health
Argus Health
Accenture
Colorcon

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