APPLICATION
NDA020215
TYPE
NDA
ORIGINAL APPROVAL
1993-06-30
LATEST ACTION
2022-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONOKET · ReferencePrescription
ISOSORBIDE MONONITRATE 20MG · TABLET · ORAL
MONOKET · ReferencePrescription
ISOSORBIDE MONONITRATE 10MG · TABLET · ORAL
Approval history
2002-05-15Manufacturing (CMC) · Supplement 13 · standardAP
2000-02-22Manufacturing (CMC) · Supplement 12 · standardAP
2000-01-19Labeling · Supplement 11 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 9 · standardAP
1999-10-26Manufacturing (CMC) · Supplement 10 · standardAP
1999-01-13Labeling · Supplement 8 · standardAP
1997-08-25Manufacturing (CMC) · Supplement 5 · standardAP
1997-08-07Manufacturing (CMC) · Supplement 6 · standardAP
1996-03-12Manufacturing (CMC) · Supplement 3 · standardAP
1995-11-20Manufacturing (CMC) · Supplement 4 · standardAP
1994-09-02Labeling · Supplement 2 · standardAP
1993-12-15Manufacturing (CMC) · Supplement 1 · standardAP
1993-06-30Type 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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