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FDA ANDA · ANDA207821

AMLODIPINE BESYLATE

Sponsor: PURACAP LABS BLU

APPLICATION
ANDA207821
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-11
LATEST ACTION
2018-04-23
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

2018-04-23Labeling · Supplement 2 · standardAP
2018-04-23Labeling · Supplement 1 · standardAP
2016-07-11UNKNOWN · Original · standardAP
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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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