APPLICATION
ANDA072556
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-28
LATEST ACTION
2016-04-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
NIFEDIPINEDiscontinued
NIFEDIPINE 20MG · CAPSULE · ORAL
Approval history
2016-04-12Labeling · Supplement 37 · standardAP
2014-12-11Labeling · Supplement 36 · standardAP
2011-12-13Labeling · Supplement 34AP
2007-02-08Manufacturing (CMC) · Supplement 28AP
2004-08-04Labeling · Supplement 26AP
2003-01-06Manufacturing (CMC) · Supplement 21AP
2002-08-20Labeling · Supplement 20AP
2001-11-02Manufacturing (CMC) · Supplement 17AP
2001-08-22Labeling · Supplement 18AP
1998-02-09Labeling · Supplement 16AP
1997-10-01Labeling · Supplement 15AP
1996-10-18Labeling · Supplement 14AP
1996-08-28Labeling · Supplement 13AP
1996-04-22Labeling · Supplement 12AP
1996-01-18Manufacturing (CMC) · Supplement 11AP
1992-08-10Labeling · Supplement 9AP
1992-07-14Labeling · Supplement 8AP
1992-03-24Labeling · Supplement 7AP
1992-02-11Labeling · Supplement 6AP
1992-01-22Manufacturing (CMC) · Supplement 4AP
1992-01-22Manufacturing (CMC) · Supplement 5AP
1990-11-28Labeling · Supplement 2AP
1989-04-28OriginalAP
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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