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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 202377


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NDA 202377 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Mylan, Novel Labs Inc, Strides Pharma, Teva Pharms Usa, and Torrent, and is included in nine NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.
Summary for 202377

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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