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FDA ANDA · ANDA077759

AMLODIPINE BESYLATE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA077759
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-09
LATEST ACTION
2018-04-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2018-04-26Labeling · Supplement 10 · standardAP
2015-09-24Labeling · Supplement 9 · standardAP
2014-09-26Labeling · Supplement 8 · standardAP
2012-01-03Labeling · Supplement 7AP
2010-04-30Labeling · Supplement 5AP
2007-07-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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