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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203145

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NDA 203145 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Watson Labs Teva, 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 203145

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

Pharmacology for NDA: 203145

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

Suppliers and Packaging for NDA: 203145

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203145 ANDA Macleods Pharmaceuticals Limited 33342-074 33342-074-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-074-44)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203145 ANDA Macleods Pharmaceuticals Limited 33342-074 33342-074-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-074-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Apr 19, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Apr 19, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Apr 19, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
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