Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016059
Company: EGALET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOCIN INDOMETHACIN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
INDOCIN INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
06/10/1965 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/26/2019 SUPPL-100 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016059Orig1s100ltr.pdf
05/09/2016 SUPPL-99 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf
05/09/2016 SUPPL-98 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf
01/30/2007 SUPPL-97 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-96 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf
03/24/2005 SUPPL-95 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf
12/01/1997 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1996 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

10/31/2001 SUPPL-88 Labeling

Label is not available on this site.

10/24/1994 SUPPL-87 Labeling

Label is not available on this site.

09/13/1994 SUPPL-86 Labeling

Label is not available on this site.

08/18/1994 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1994 SUPPL-84 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1994 SUPPL-83 Labeling

Label is not available on this site.

09/26/1994 SUPPL-82 Labeling

Label is not available on this site.

04/04/1991 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

05/25/1989 SUPPL-78 Labeling

Label is not available on this site.

01/06/1989 SUPPL-77 Labeling

Label is not available on this site.

01/09/1989 SUPPL-75 Labeling

Label is not available on this site.

05/03/1988 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

01/06/1989 SUPPL-73 Labeling

Label is not available on this site.

06/03/1988 SUPPL-71 Labeling

Label is not available on this site.

09/22/1986 SUPPL-68 Labeling

Label is not available on this site.

08/15/1986 SUPPL-67 Labeling

Label is not available on this site.

06/04/1986 SUPPL-65 Labeling

Label is not available on this site.

08/15/1986 SUPPL-62 Labeling

Label is not available on this site.

07/23/1985 SUPPL-61 Labeling

Label is not available on this site.

11/27/1984 SUPPL-60 Labeling

Label is not available on this site.

12/06/1984 SUPPL-59 Labeling

Label is not available on this site.

06/25/1984 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/11/1983 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/19/1983 SUPPL-52 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/18/1983 SUPPL-51 Labeling

Label is not available on this site.

01/31/1983 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1984 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/03/1982 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/06/1986 SUPPL-45 Efficacy

Label is not available on this site.

04/09/1981 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1980 SUPPL-43 Labeling

Label is not available on this site.

07/29/1983 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/28/1981 SUPPL-41 Labeling

Label is not available on this site.

10/26/1979 SUPPL-40 Labeling

Label is not available on this site.

08/08/1979 SUPPL-39 Labeling

Label is not available on this site.

09/24/1979 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

01/29/1979 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1978 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1979 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1978 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-31 Labeling

Label is not available on this site.

06/29/1976 SUPPL-30 Labeling

Label is not available on this site.

10/07/1981 SUPPL-29 Labeling

Label is not available on this site.

08/27/1976 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/26/2019 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016059s100lbl.pdf
05/09/2016 SUPPL-99 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
05/09/2016 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
05/09/2016 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
05/09/2016 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
05/09/2016 SUPPL-98 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
05/09/2016 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf
01/30/2007 SUPPL-97 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf
01/26/2006 SUPPL-96 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf

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