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Fuji
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US Department of Justice
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Dow
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201593

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NDA 201593 describes AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo Pharma Ltd, Lupin Ltd, Par Pharm, Teva Pharms, and Torrent Pharms Ltd, and is included in five NDAs. It is available from six suppliers. Additional details are available on the AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 201593
Pharmacology for NDA: 201593
Suppliers and Packaging for NDA: 201593
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593 ANDA Torrent Pharmaceuticals Limited 13668-325 N 13668-325-05
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201593 ANDA Torrent Pharmaceuticals Limited 13668-325 N 13668-325-74

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG;160MG
Approval Date:Jun 3, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;25MG;160MG
Approval Date:Jun 3, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG;160MG
Approval Date:Jun 3, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Cipla
UBS
Cerilliant
Express Scripts
AstraZeneca
Julphar
QuintilesIMS

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