APPLICATION
ANDA040009
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-30
LATEST ACTION
2014-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 40MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2014-11-19Manufacturing (CMC) · Supplement 8 · unknownAP
2002-05-07Labeling · Supplement 2AP
2001-04-23Manufacturing (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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