An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 204592
Company: ZYLA

Medication Guide

Summary Review

Products on NDA 204592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZORVOLEX	DICLOFENAC	18MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
ZORVOLEX	DICLOFENAC	35MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204592

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
04/28/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204592s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204592Orig1s013ltr.pdf
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.

Labels for NDA 204592

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204592s013lbl.pdf
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

Top