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FDA ANDA · ANDA077073

AMLODIPINE BESYLATE

Sponsor: CIPLA

APPLICATION
ANDA077073
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-26
LATEST ACTION
2018-04-20
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

2018-04-20Labeling · Supplement 15 · standardAP
2018-04-20Labeling · Supplement 16 · standardAP
2016-01-28Labeling · Supplement 8 · standardAP
2015-10-02Labeling · Supplement 6 · standardAP
2014-09-26Labeling · Supplement 2 · standardAP
2007-09-26OriginalAP
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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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