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Details for New Drug Application (NDA): 203145

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NDA 203145 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: 203145

Tradename:
VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:
Macleods Pharms Ltd
Ingredient:
hydrochlorothiazide; valsartan
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 33342-074-10 90 TABLET, FILM COATED in 1 BOTTLE (33342-074-10)
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)

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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