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FDA ANDA · ANDA077899

NIFEDIPINE

Sponsor: PH HEALTH

APPLICATION
ANDA077899
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-13
LATEST ACTION
2014-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

NIFEDIPINEDiscontinued
NIFEDIPINE 90MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEDiscontinued
NIFEDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
NIFEDIPINEDiscontinued
NIFEDIPINE 60MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2014-09-10Labeling · Supplement 9AP
2012-05-25Labeling · Supplement 8AP
2011-04-29Labeling · Supplement 17AP
2010-11-30Labeling · Supplement 16AP
2006-12-13OriginalAP
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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