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FDA ANDA · ANDA090752

AMLODIPINE BESYLATE

Sponsor: CHINA RESOURCES

APPLICATION
ANDA090752
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-15
LATEST ACTION
2018-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2018-04-23Labeling · Supplement 3 · standardAP
2018-04-23Labeling · Supplement 4 · standardAP
2016-05-16Manufacturing (CMC) · Supplement 1AP
2016-01-14Labeling · Supplement 2 · standardAP
2011-04-15OriginalAP
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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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