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Details for New Drug Application (NDA): 079047

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NDA 079047 describes AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Mylan, Dr Reddys Labs Inc, Watson Labs Inc, Lupin Pharms, Teva Pharms, Par Pharm, and Watson Labs, and is included in eleven NDAs. It is available from twenty 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 forty-nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

Summary for NDA: 079047

Tradename:
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Applicant:
Mylan
Ingredient:
amlodipine besylate; benazepril hydrochloride
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079047

Suppliers and Packaging for NDA: 079047

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 079047 ANDA Mylan Pharmaceuticals Inc. 0378-6899 0378-6899-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6899-01)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL 079047 ANDA Mylan Pharmaceuticals Inc. 0378-6900 0378-6900-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6900-01)

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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