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Generated: November 14, 2018

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Details for New Drug Application (NDA): 200435

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NDA 200435 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Pharmacology for NDA: 200435
Suppliers and Packaging for NDA: 200435
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 200435 ANDA Teva Pharmaceuticals USA, Inc. 0093-7037 0093-7037-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7037-56)
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE amlodipine besylate; hydrochlorothiazide; valsartan TABLET;ORAL 200435 ANDA Teva Pharmaceuticals USA, Inc. 0093-7037 0093-7037-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7037-98)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG;160MG
Approval Date:Sep 25, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;25MG;160MG
Approval Date:Sep 25, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;25MG;160MG
Approval Date:Sep 25, 2012TE:ABRLD:No

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