← FDA DRUG APPROVALS
FDA ANDA · ANDA078414
AMLODIPINE BESYLATE 2.5 MG
amlodipine besylate
Sponsor: OXFORD PHARMS
APPLICATION
ANDA078414
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-07
LATEST ACTION
2018-04-02
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
2018-04-02Labeling · Supplement 13 · standardAP
2015-09-18Labeling · Supplement 3AP
2015-09-18Labeling · Supplement 11 · standardAP
2015-09-18Labeling · Supplement 7 · standardAP
2010-04-30Labeling · Supplement 2AP
2010-04-07OriginalAP
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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