Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018829
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Discontinued None No No
INDOMETHACIN INDOMETHACIN 25MG 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
06/21/1984 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
05/09/2016 SUPPL-22 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018829Orig1s022ltr.pdf
07/26/1996 SUPPL-21 Labeling

Label is not available on this site.

06/07/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/27/1992 SUPPL-19 Labeling

Label is not available on this site.

04/29/1991 SUPPL-18 Labeling

Label is not available on this site.

06/08/1989 SUPPL-17 Labeling

Label is not available on this site.

03/21/1989 SUPPL-16 Labeling

Label is not available on this site.

11/09/1988 SUPPL-15 Labeling

Label is not available on this site.

05/02/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/28/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/14/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/14/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 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-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf
05/09/2016 SUPPL-22 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf

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