APPLICATION
NDA019546
TYPE
NDA
ORIGINAL APPROVAL
1990-12-20
LATEST ACTION
2005-05-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DYNACIRC · ReferenceDiscontinued
ISRADIPINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DYNACIRC · ReferenceDiscontinued
ISRADIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2002-06-14Manufacturing (CMC) · Supplement 26 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 25 · standardAP
2001-05-30Manufacturing (CMC) · Supplement 24 · standardAP
1999-12-14Manufacturing (CMC) · Supplement 23 · standardAP
1999-05-07Manufacturing (CMC) · Supplement 22 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 21 · standardAP
1997-01-14Manufacturing (CMC) · Supplement 20 · standardAP
1995-11-27Manufacturing (CMC) · Supplement 17 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 16 · standardAP
1995-05-04Labeling · Supplement 13 · standardAP
1995-04-04Manufacturing (CMC) · Supplement 15 · standardAP
1993-11-03Labeling · Supplement 12 · standardAP
1993-03-23Manufacturing (CMC) · Supplement 11 · standardAP
1993-02-08Manufacturing (CMC) · Supplement 10 · standardAP
1992-08-17Manufacturing (CMC) · Supplement 9 · standardAP
1991-11-06Manufacturing (CMC) · Supplement 8 · standardAP
1991-11-06Manufacturing (CMC) · Supplement 7 · standardAP
1991-08-05Manufacturing (CMC) · Supplement 6 · standardAP
1991-06-13Labeling · Supplement 2 · standardAP
1991-06-13Labeling · Supplement 5 · standardAP
1991-06-12Manufacturing (CMC) · Supplement 4 · standardAP
1991-04-30Manufacturing (CMC) · Supplement 1 · 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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