APPLICATION
ANDA075037
TYPE
ANDA
ORIGINAL APPROVAL
1998-10-30
LATEST ACTION
2001-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 20MG · TABLET · ORAL
ISOSORBIDE MONONITRATEPrescription
ISOSORBIDE MONONITRATE 10MG · TABLET · ORAL
Approval history
2001-11-02Manufacturing (CMC) · Supplement 3AP
2000-04-17Labeling · Supplement 2AP
1999-11-24Labeling · 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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