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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201087

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NDA 201087 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 seven 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. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 201087
Pharmacology for NDA: 201087
Suppliers and Packaging for NDA: 201087
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 201087 ANDA Par Pharmaceutical, Inc. 49884-172 N 49884-172-05
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 201087 ANDA Par Pharmaceutical, Inc. 49884-172 N 49884-172-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG;160MG
Approval Date:Jun 1, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;25MG;160MG
Approval Date:Jun 1, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG;160MG
Approval Date:Jun 1, 2015TE:ABRLD:No

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