APPLICATION
NDA016192
TYPE
NDA
ORIGINAL APPROVAL
1968-01-16
LATEST ACTION
1999-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SORBITRATEDiscontinued
ISOSORBIDE DINITRATE 10MG · TABLET · ORAL
SORBITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
Approval history
1999-01-26Labeling · Supplement 43 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 42 · standardAP
1996-04-01Manufacturing (CMC) · Supplement 41 · standardAP
1981-07-09Labeling · Supplement 25 · standardAP
1980-08-05Manufacturing (CMC) · Supplement 22 · standardAP
1968-01-16Type 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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