APPLICATION
NDA019478
TYPE
NDA
ORIGINAL APPROVAL
1985-11-27
LATEST ACTION
1997-12-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ADALATDiscontinued
NIFEDIPINE 20MG · CAPSULE · ORAL
ADALATDiscontinued
NIFEDIPINE 10MG · CAPSULE · ORAL
Approval history
1997-12-22Manufacturing (CMC) · Supplement 12 · standardAP
1996-03-22Labeling · Supplement 11 · standardAP
1993-09-22Labeling · Supplement 10 · standardAP
1992-01-23Labeling · Supplement 9 · standardAP
1991-09-13Labeling · Supplement 7 · standardAP
1991-09-13Labeling · Supplement 8 · standardAP
1989-11-21Labeling · Supplement 6 · standardAP
1989-08-10Manufacturing (CMC) · Supplement 5 · standardAP
1988-10-26Manufacturing (CMC) · Supplement 4 · standardAP
1988-07-21Manufacturing (CMC) · Supplement 3 · standardAP
1986-10-07Manufacturing (CMC) · Supplement 2 · standardAP
1986-09-17Labeling · Supplement 1 · standardAP
1985-11-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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