MedPath

AMLODIPINE BESYLATE

Amlodipine Besylate Tablets Rx only

Approved
Approval ID

c32059ed-73cd-4a2c-9690-276e7068041e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 12, 2010

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

AMLODIPINE BESYLATE

PRODUCT DETAILS

NDC Product Code16590-295
Application NumberANDA078500
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 12, 2010
Generic NameAMLODIPINE BESYLATE

INGREDIENTS (1)

AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

AMLODIPINE BESYLATE - FDA Drug Approval Details