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Details for New Drug Application (NDA): 205137

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NDA 205137 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Par Pharm Inc, Aurobindo Pharma Ltd, Alembic Pharms Ltd, Novel Labs Inc, Teva Pharms Usa, Invagen Pharms, Lupin, Torrent Pharms Ltd, and Mylan Pharms Inc, and is included in nine NDAs. It is available from twelve 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 forty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.

Summary for NDA: 205137

Invagen Pharms
amlodipine besylate; valsartan
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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

Summary 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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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.