Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200540
Company: EXELA HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Discontinued None No No
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/14/2014 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/27/2017 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/27/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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