APPLICATION
ANDA075522
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-17
LATEST ACTION
2025-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 30MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 60MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-07-14Labeling · Supplement 31 · standardAP
2022-01-26Labeling · Supplement 22 · standardAP
2014-10-31Manufacturing (CMC) · Supplement 12AP
2011-04-29Labeling · Supplement 11AP
2004-03-24Labeling · Supplement 9AP
2002-02-19Manufacturing (CMC) · Supplement 7AP
2002-02-19Labeling · Supplement 8AP
2001-09-26Manufacturing (CMC) · Supplement 6AP
2001-04-04Labeling · Supplement 5AP
2001-04-04Manufacturing (CMC) · Supplement 4AP
2001-01-08Manufacturing (CMC) · Supplement 1AP
2000-12-22Labeling · Supplement 3AP
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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