APPLICATION
NDA016776
TYPE
NDA
ORIGINAL APPROVAL
1970-12-07
LATEST ACTION
1999-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
SORBITRATEDiscontinued
ISOSORBIDE DINITRATE 10MG · TABLET, CHEWABLE · ORAL
SORBITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET, CHEWABLE · ORAL
Approval history
1999-01-26Labeling · Supplement 36 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 35 · standardAP
1996-04-01Manufacturing (CMC) · Supplement 34 · standardAP
1982-01-21Manufacturing (CMC) · Supplement 23 · standardAP
1977-11-28Manufacturing (CMC) · Supplement 15 · standardAP
1970-12-07Type 3 - New Dosage Form · 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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