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FDA ANDA · ANDA078043

AMLODIPINE BESYLATE

Sponsor: LUPIN

APPLICATION
ANDA078043
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-12
LATEST ACTION
2018-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2018-05-21Labeling · Supplement 19 · standardAP
2015-09-18Labeling · Supplement 17 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2013-08-26Labeling · Supplement 13 · standardAP
2010-10-22Labeling · Supplement 8AP
2007-07-12OriginalAP
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Related on SPEQ

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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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