Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017814
Company: EGALET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOCIN INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No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
08/13/1984 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf
05/09/2016 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf
01/30/2007 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf
01/26/2006 SUPPL-39 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf
03/24/2005 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf
02/04/2000 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/29/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1997 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2001 SUPPL-28 Labeling

Label is not available on this site.

10/24/1994 SUPPL-27 Labeling

Label is not available on this site.

09/13/1994 SUPPL-26 Labeling

Label is not available on this site.

12/30/1994 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1994 SUPPL-24 Labeling

Label is not available on this site.

05/23/1989 SUPPL-21 Labeling

Label is not available on this site.

01/06/1989 SUPPL-20 Labeling

Label is not available on this site.

01/09/1989 SUPPL-18 Labeling

Label is not available on this site.

03/10/1988 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1989 SUPPL-16 Labeling

Label is not available on this site.

06/03/1988 SUPPL-13 Labeling

Label is not available on this site.

09/19/1986 SUPPL-11 Labeling

Label is not available on this site.

08/15/1986 SUPPL-10 Labeling

Label is not available on this site.

06/04/1986 SUPPL-9 Labeling

Label is not available on this site.

01/06/1986 SUPPL-5 Labeling

Label is not available on this site.

07/23/1985 SUPPL-4 Labeling

Label is not available on this site.

11/27/1984 SUPPL-2 Labeling

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-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
05/09/2016 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
05/09/2016 SUPPL-42 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
05/09/2016 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
05/09/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf
01/30/2007 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf
01/26/2006 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf

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