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Serving leading biopharmaceutical companies globally:

Chubb
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UBS
QuintilesIMS
Merck
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Healthtrust
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Medtronic
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Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202519

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NDA 202519 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Teva, Mylan Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Alembic Pharms Ltd, and Prinston Inc, and is included in eight NDAs. It is available from twenty-two suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 202519

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202519

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 202519

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL 202519 ANDA Northwind Pharmaceuticals 51655-951 51655-951-52 30 TABLET in 1 BOTTLE, DISPENSING (51655-951-52)
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL 202519 ANDA Northwind Pharmaceuticals 51655-953 51655-953-52 30 TABLET, FILM COATED in 1 BOTTLE (51655-953-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Mar 21, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
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Accenture
Federal Trade Commission
Harvard Business School
Chinese Patent Office
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