Dihydropyridine derivatives

Amlodipine Maleate; Benazepril Hydrochloride

Approved 15 Sept 2006OralCapsule

The FDA lists this product in 4 strengths and forms.

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Composition

Active ingredients: AMLODIPINE MALEATE 5MG; BENAZEPRIL HYDROCHLORIDE 20MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

AMLODIPINE MALEATE 5MG; BENAZEPRIL HYDROCHLORIDE 20MG · CapsuleThis page
AMLODIPINE MALEATE 2.5MG; BENAZEPRIL HYDROCHLORIDE 10MG · CapsuleNDA021714-001 · Tentative approval
AMLODIPINE MALEATE 10MG; BENAZEPRIL HYDROCHLORIDE 20MG · CapsuleNDA021714-004 · Tentative approval
AMLODIPINE MALEATE 5MG; BENAZEPRIL HYDROCHLORIDE 10MG · CapsuleNDA021714-002 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application NDA021714.

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At a glance

Brand name: Amlodipine Maleate; Benazepril Hydrochloride
Active substance: amlodipine maleate
Drug class: Dihydropyridine derivatives, ACE inhibitors, plain, ACE inhibitors and calcium channel blockers
Group: ACE inhibitors and sartans
Route: Oral
Dosage form: Capsule
Applicant: DR Reddys Labs LTD
Status: Tentative approval
FDA approval: 15 Sept 2006
Application: NDA021714-003
RxCUI: 214223