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Details for New Drug Application (NDA): 203026

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NDA 203026 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Inc, Mylan Pharms Inc, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Alembic Ltd, and Prinston Inc, and is included in eight NDAs. It is available from twenty-three 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. Thirty suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 203026

Tradename:
VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:
Apotex Inc
Ingredient:
hydrochlorothiazide; valsartan
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203026

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

Suppliers and Packaging for NDA: 203026

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL 203026 ANDA A-S Medication Solutions 50090-1707 50090-1707-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-1707-0)
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL 203026 ANDA Apotex Corp. 60505-3806 60505-3806-5 500 TABLET, FILM COATED in 1 BOTTLE (60505-3806-5)

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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