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FDA Drug information

Amlodipine Besylate

Read time: 1 mins
Marketing start date: 18 Jun 2024

Summary of product characteristics


Effective Time

20230918

Version

12

Spl Product Data Elements

Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;7 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;3 Amlodipine Besylate Amlodipine Besylate AMLODIPINE BESYLATE AMLODIPINE MAGNESIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND Z;5

Application Number

ANDA078226

Brand Name

Amlodipine Besylate

Generic Name

Amlodipine Besylate

Product Ndc

65841-622

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-620-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Rx only 90 tablets NDC 65841-621-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 5 mg Rx only 90 tablets NDC 65841-622-16 in bottle of 90 tablets Amlodipine Besylate Tablets USP, 10 mg Rx only 90 tablets Amlodipine Besylate Tablets USP, 2.5 mg Amlodipine Besylate Tablets USP, 5 mg Amlodipine Besylate Tablets USP, 10 mg

Spl Medguide

SPL MEDGUIDE

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