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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090364

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NDA 090364 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 nineteen 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-four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

Summary for 090364

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090364

Suppliers and Packaging for NDA: 090364

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 090364 ANDA Actavis Pharma, Inc. 0591-3761 0591-3761-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0591-3761-05)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 090364 ANDA Actavis Pharma, Inc. 0591-3761 0591-3761-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-3761-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Jul 5, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE;40MG
Approval Date:Jul 5, 2011TE:ABRLD:No


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