APPLICATION
ANDA200158
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-09
LATEST ACTION
2023-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DICLOFENAC SODIUM AND MISOPROSTOLDiscontinued
DICLOFENAC SODIUM 75MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUM AND MISOPROSTOLDiscontinued
DICLOFENAC SODIUM 50MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-05-19Labeling · Supplement 9 · standardAP
2023-05-19Labeling · Supplement 7 · standardAP
2023-05-19Labeling · Supplement 13 · standardAP
2023-05-19Labeling · Supplement 11 · standardAP
2023-05-19Labeling · Supplement 8 · standardAP
2023-05-19Labeling · Supplement 14 · standardAP
2023-05-19Labeling · Supplement 12 · standardAP
2023-05-19Labeling · Supplement 10 · standardAP
2013-05-09Not 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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