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FDA ANDA · ANDA201089
DICLOFENAC SODIUM AND MISOPROSTOL
Sponsor: ACTAVIS LABS FL INC
APPLICATION
ANDA201089
TYPE
ANDA
ORIGINAL APPROVAL
2012-07-09
LATEST ACTION
2015-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DICLOFENAC SODIUM AND MISOPROSTOLPrescription
DICLOFENAC SODIUM 75MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUM AND MISOPROSTOLPrescription
DICLOFENAC SODIUM 50MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2015-09-16Labeling · Supplement 6 · standardAP
2015-09-16Labeling · Supplement 2 · 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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