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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202239


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NDA 202239 describes AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Amneal, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Norvium Bioscience, Strides Pharma, Teva Pharms, Watson Labs, and Watson Labs Inc, and is included in twelve NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
Suppliers and Packaging for NDA: 202239
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 202239 ANDA AvKARE 42291-011 42291-011-01 100 CAPSULE in 1 BOTTLE (42291-011-01)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 202239 ANDA AvKARE 42291-012 42291-012-01 100 CAPSULE in 1 BOTTLE (42291-012-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2.5MG BASE;10MG
Approval Date:Sep 5, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;10MG
Approval Date:Sep 5, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;20MG
Approval Date:Sep 5, 2012TE:ABRLD:No

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