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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090483

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NDA 090483 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan Pharms Inc, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the AMLODIPINE BESYLATE AND VALSARTAN profile page.

The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 090483
Tradename:AMLODIPINE BESYLATE AND VALSARTAN
Applicant:Mylan Pharms Inc
Ingredient:amlodipine besylate; valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090483
Suppliers and Packaging for NDA: 090483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090483 ANDA Mylan Pharmaceuticals Inc. 0378-1721 N 0378-1721-93
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090483 ANDA Mylan Pharmaceuticals Inc. 0378-1722 N 0378-1722-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Mar 30, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Mar 30, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Mar 30, 2015TE:ABRLD:No

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