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Generated: October 23, 2018

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Details for New Drug Application (NDA): 077183

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NDA 077183 describes AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs, and Watson Labs Inc, and is included in eleven 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-two suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
Pharmacology for NDA: 077183
Suppliers and Packaging for NDA: 077183
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 077183 ANDA Rebel Distributors Corp 21695-866 21695-866-90 90 CAPSULE in 1 BOTTLE (21695-866-90)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 077183 ANDA Rebel Distributors Corp 21695-916 21695-916-30 30 CAPSULE in 1 BOTTLE (21695-916-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2.5MG BASE;10MG
Approval Date:Apr 15, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;10MG
Approval Date:Apr 15, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;20MG
Approval Date:Apr 15, 2010TE:ABRLD:No

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