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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Boehringer Ingelheim

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205137

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NDA 205137 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. Twelve suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 205137
Applicant:Invagen Pharms
Ingredient:amlodipine besylate; valsartan
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;160MG
Approval Date:Sep 16, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;160MG
Approval Date:Sep 16, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;320MG
Approval Date:Sep 16, 2016TE:ABRLD:No

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Fish and Richardson
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