APPLICATION
ANDA218255
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-15
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 60MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 120MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEDiscontinued
ISOSORBIDE MONONITRATE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-02-15UNKNOWN · 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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