APPLICATION
ANDA091667
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-25
LATEST ACTION
2020-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MISOPROSTOLDiscontinued
MISOPROSTOL 0.2MG · TABLET · ORAL
MISOPROSTOLDiscontinued
MISOPROSTOL 0.1MG · TABLET · ORAL
Approval history
2020-04-13Labeling · Supplement 3 · standardAP
2020-04-13Labeling · Supplement 6 · standardAP
2012-07-25Not 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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