Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204592
Company: EGALET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZORVOLEX DICLOFENAC 18MG CAPSULE;ORAL Prescription None Yes No
ZORVOLEX DICLOFENAC 35MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/18/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204592s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204592Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf
05/09/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf
01/29/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/22/2014 SUPPL-4 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204592Orig1s004.pdf
08/11/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/22/2014 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204592Orig1s002.pdf
04/14/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
05/09/2016 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
05/09/2016 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
05/09/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
05/09/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf
08/22/2014 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf
08/22/2014 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf
10/18/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204592s000lbl.pdf

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