APPLICATION
ANDA090649
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-21
LATEST ACTION
2016-02-03
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
2016-02-03Labeling · Supplement 13 · standardAP
2015-01-20Labeling · Supplement 8 · standardAP
2015-01-20Labeling · Supplement 11 · standardAP
2013-08-16Labeling · Supplement 6 · standardAP
2012-10-29Manufacturing (CMC) · Supplement 5AP
2011-07-29Labeling · Supplement 3AP
2010-06-21OriginalAP
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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