APPLICATION
ANDA200495
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-03
LATEST ACTION
2011-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 60MG · TABLET, EXTENDED RELEASE · ORAL
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2011-06-03Not Applicable · OriginalAP
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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