APPLICATION
ANDA084204
TYPE
ANDA
ORIGINAL APPROVAL
1978-12-01
LATEST ACTION
1998-12-01
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 2.5MG · TABLET · SUBLINGUAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 38AP
1994-12-23Manufacturing (CMC) · Supplement 37AP
1994-10-11Manufacturing (CMC) · Supplement 36AP
1992-04-03Manufacturing (CMC) · Supplement 34AP
1992-04-03Manufacturing (CMC) · Supplement 32AP
1992-03-16Labeling · Supplement 35AP
1991-12-19Labeling · Supplement 31AP
1990-07-25Labeling · Supplement 30AP
1987-06-17Manufacturing (CMC) · Supplement 26AP
1987-03-25Manufacturing (CMC) · Supplement 27AP
1986-09-18Manufacturing (CMC) · Supplement 22AP
1986-09-18Manufacturing (CMC) · Supplement 23AP
1984-07-13Manufacturing (CMC) · Supplement 19AP
1984-02-08Manufacturing (CMC) · Supplement 17AP
1982-02-24Manufacturing (CMC) · Supplement 15AP
1978-12-01OriginalAP
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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