Application Nr Approved Date Route Status External Links
ANDA077955 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Amlodipine Besylate, Usp Is A Calcium Channel Blocker And May Be Used Alone Or In Combination With Other Antihypertensive And Antianginal Agents For The Treatment Of: • Hypertension ( 1.1 ) • Coronary Artery Disease ( 1.2 ) • Chronic Stable Angina • Vasospastic Angina (Prinzmetal’s Or Variant Angina) • Angiographically Documented Coronary Artery • Disease In Patients Without Heart Failure Or An Ejection Fraction < 40% 1.1. Hypertension Amlodipine Besylate Tablets, Usp Are Indicated For The Treatment Of Hypertension. It May Be Used Alone Or In Combination With Other Antihypertensive Agents. 1.2. Coronary Artery Disease (Cad) Chronic Stable Angina Amlodipine Besylate Tablets, Usp Are Indicated For The Symptomatic Treatment Of Chronic Stable Angina. Amlodipine Besylate Tablets, Usp May Be Used Alone Or In Combination With Other Antianginal Agents. Vasospastic Angina (Prinzmetal’s Or Variant Angina) Amlodipine Besylate Tablets, Usp Are Indicated For The Treatment Of Confirmed Or Suspected Vasospastic Angina. Amlodipine Besylate Tablets, Usp May Be Used As Monotherapy Or In Combination With Other Antianginal Agents. Angiographically Documented Cad In Patients With Recently Documented Cad By Angiography And Without Heart Failure Or An Ejection Fraction <40%, Amlodipine Besylate Tablets, Usp Are Indicated To Reduce The Risk Of Hospitalization Due To Angina And To Reduce The Risk Of A Coronary Revascularization Procedure.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amlodipine Besylate AMLODIPINE BESYLATE ZINC100001965

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