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FDA ANDA · ANDA078231

AMLODIPINE BESYLATE

Sponsor: SUN PHARM INDS INC

APPLICATION
ANDA078231
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-30
LATEST ACTION
2009-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2009-01-15Labeling · Supplement 2AP
2007-11-30OriginalAP
VIEW ON DRUGS@FDA ↗

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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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