APPLICATION
ANDA075395
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-16
LATEST ACTION
2015-03-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 120MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 30MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 60MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-03-04Labeling · Supplement 25AP
2007-10-31Labeling · Supplement 18AP
2007-06-14Manufacturing (CMC) · Supplement 12AP
2007-06-14Labeling · Supplement 13AP
2002-09-09Manufacturing (CMC) · Supplement 6AP
2002-09-09Manufacturing (CMC) · Supplement 5AP
2002-08-23Manufacturing (CMC) · Supplement 4AP
2002-02-19Manufacturing (CMC) · Supplement 3AP
2001-03-23Manufacturing (CMC) · Supplement 2AP
2000-08-10Manufacturing (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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