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FDA Product

Amlodipine Besylate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amlodipine Besylate

63304-875

Regulatory Information

63304-875

ANDA077974

C73584

May 5, 2015

USA

These highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets.Amlodipine besylate tablets, for oral administrationInitial U.S. Approval: 1987

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

937890044

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

AMLODIPINE

Code: 1J444QC288

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