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Generated: April 19, 2019

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Details for New Drug Application (NDA): 077375

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NDA 077375 describes AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs, and Watson Labs Inc, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE profile page.

The generic ingredient in AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 2.5MG BASE;10MG
Approval Date:May 21, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 5MG BASE;10MG
Approval Date:May 21, 2010TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 5MG BASE;20MG
Approval Date:May 21, 2010TE:RLD:No

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