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FDA ANDA · ANDA076692

AMLODIPINE BESYLATE

Sponsor: CHARTWELL RX

APPLICATION
ANDA076692
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-20
LATEST ACTION
2012-01-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL
AMLODIPINE BESYLATEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL

Approval history

2012-01-23Labeling · Supplement 4AP
2011-07-22Labeling · Supplement 3AP
2010-04-29Labeling · Supplement 2AP
2007-07-20OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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