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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Novartis
Deloitte
Chubb
US Department of Justice
Cipla
McKinsey
Medtronic
McKesson
Harvard Business School

Generated: December 14, 2017

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 ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.

Summary for 090483

Tradename:1
Applicant:1
Ingredient:1
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 0378-1721-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1721-93)
AMLODIPINE BESYLATE AND VALSARTAN amlodipine besylate; valsartan TABLET;ORAL 090483 ANDA Mylan Pharmaceuticals Inc. 0378-1722 0378-1722-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1722-93)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Fuji
Federal Trade Commission
Baxter
McKesson
QuintilesIMS
Covington
Medtronic
Citi

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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