Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018858
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Discontinued None No No
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Discontinued None No 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
04/20/1984 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2016 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/09/2016 SUPPL-42 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,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/2016/018858s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018858Orig1s041,s042ltr.pdf
04/28/2008 SUPPL-38 Labeling

Label is not available on this site.

06/07/2006 SUPPL-32 Labeling

Label is not available on this site.

09/26/2002 SUPPL-28 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/22/2002 SUPPL-27 Labeling

Label is not available on this site.

02/25/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/18/1996 SUPPL-24 Labeling

Label is not available on this site.

10/05/1993 SUPPL-23 Labeling

Label is not available on this site.

05/02/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/20/1993 SUPPL-20 Labeling

Label is not available on this site.

12/10/1992 SUPPL-19 Labeling

Label is not available on this site.

01/31/1990 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/20/1989 SUPPL-17 Labeling

Label is not available on this site.

06/22/1989 SUPPL-16 Labeling

Label is not available on this site.

04/26/1989 SUPPL-15 Labeling

Label is not available on this site.

04/12/1988 SUPPL-14 Labeling

Label is not available on this site.

09/24/1987 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/20/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/31/1985 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-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf
05/09/2016 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf
05/09/2016 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf
05/09/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018858s041s042lbl.pdf

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