APPLICATION
ANDA213057
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-20
LATEST ACTION
2019-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 40MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 20MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 30MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 10MG · TABLET · ORAL
Approval history
2019-11-20UNKNOWN · 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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