APPLICATION
ANDA086221
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-07
LATEST ACTION
2020-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
Approval history
2020-02-20Labeling · Supplement 51 · standardAP
2008-02-21Labeling · Supplement 48AP
2001-06-07Manufacturing (CMC) · Supplement 45AP
1999-09-22Labeling · Supplement 44AP
1999-05-05Manufacturing (CMC) · Supplement 42AP
1999-03-25Labeling · Supplement 40AP
1999-03-25Manufacturing (CMC) · Supplement 39AP
1999-03-11Manufacturing (CMC) · Supplement 41AP
1996-12-02Manufacturing (CMC) · Supplement 38AP
1996-09-13Labeling · Supplement 37AP
1996-02-27Manufacturing (CMC) · Supplement 36AP
1995-03-20Manufacturing (CMC) · Supplement 35AP
1991-05-21Labeling · Supplement 34AP
1989-11-03Labeling · Supplement 33AP
1989-06-13Labeling · Supplement 32AP
1988-01-07OriginalAP
1985-11-12Manufacturing (CMC) · Supplement 30AP
1985-11-12Manufacturing (CMC) · Supplement 29AP
1985-11-12Manufacturing (CMC) · Supplement 31AP
1983-12-15Manufacturing (CMC) · Supplement 17AP
1982-12-28Manufacturing (CMC) · Supplement 13AP
1982-12-28Manufacturing (CMC) · Supplement 14AP
1982-04-28Manufacturing (CMC) · Supplement 11AP
1982-04-28Manufacturing (CMC) · Supplement 2AP
1982-04-28Manufacturing (CMC) · Supplement 9AP
1982-04-28Manufacturing (CMC) · Supplement 12AP
1982-04-28Manufacturing (CMC) · Supplement 10AP
1982-04-28Manufacturing (CMC) · Supplement 5AP
1982-04-28Manufacturing (CMC) · Supplement 1AP
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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