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Serving leading biopharmaceutical companies globally:

Citi
Fuji
Cipla
Teva
Johnson and Johnson
Baxter
Fish and Richardson
Farmers Insurance
QuintilesIMS
Novartis

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090149

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NDA 090149 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 090149
Pharmacology for NDA: 090149
Suppliers and Packaging for NDA: 090149
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 090149 ANDA Rebel Distributors Corp 42254-073 E 42254-073-30
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 090149 ANDA Rebel Distributors Corp 42254-074 E 42254-074-30

Profile for product number 001

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

Profile 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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US Department of Justice
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