Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018185
Company: EGALET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOCIN SR INDOMETHACIN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No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
02/23/1982 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
03/26/2019 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018185Orig1s057ltr.pdf
05/09/2016 SUPPL-56 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf
05/09/2016 SUPPL-55 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf
10/11/2001 SUPPL-53 Labeling

Label is not available on this site.

10/07/1997 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

03/01/1996 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

10/31/2001 SUPPL-48 Labeling

Label is not available on this site.

10/24/1994 SUPPL-47 Labeling

Label is not available on this site.

09/13/1994 SUPPL-46 Labeling

Label is not available on this site.

09/14/1994 SUPPL-45 Labeling

Label is not available on this site.

08/18/1994 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1994 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1994 SUPPL-42 Labeling

Label is not available on this site.

09/26/1994 SUPPL-41 Labeling

Label is not available on this site.

05/25/1989 SUPPL-38 Labeling

Label is not available on this site.

01/06/1989 SUPPL-37 Labeling

Label is not available on this site.

01/09/1989 SUPPL-35 Labeling

Label is not available on this site.

03/10/1988 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1989 SUPPL-33 Labeling

Label is not available on this site.

02/10/1989 SUPPL-31 Labeling

Label is not available on this site.

06/03/1988 SUPPL-30 Labeling

Label is not available on this site.

09/19/1986 SUPPL-26 Labeling

Label is not available on this site.

08/15/1986 SUPPL-24 Labeling

Label is not available on this site.

07/23/1985 SUPPL-22 Labeling

Label is not available on this site.

11/27/1984 SUPPL-21 Labeling

Label is not available on this site.

09/30/1985 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/21/1985 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/21/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/20/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/27/1984 SUPPL-15 Labeling

Label is not available on this site.

05/03/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/25/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/06/1986 SUPPL-11 Labeling

Label is not available on this site.

10/31/1983 SUPPL-8 Labeling

Label is not available on this site.

10/05/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1983 SUPPL-6 Labeling

Label is not available on this site.

02/01/1983 SUPPL-5 Labeling

Label is not available on this site.

10/19/1982 SUPPL-4 Labeling

Label is not available on this site.

02/01/1983 SUPPL-2 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-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018185s057lbl.pdf
05/09/2016 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf
05/09/2016 SUPPL-56 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf
05/09/2016 SUPPL-55 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf
05/09/2016 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf

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