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FDA ANDA · ANDA200540

DICLOFENAC SODIUM AND MISOPROSTOL

Sponsor: EXELA HOLDINGS

APPLICATION
ANDA200540
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-14
LATEST ACTION
2017-12-27
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

2017-12-27Labeling · Supplement 5 · standardAP
2017-12-27Labeling · Supplement 3 · standardAP
2017-12-27Labeling · Supplement 6 · standardAP
2014-03-14Not Applicable · OriginalAP
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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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