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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018332
Company: ZYLA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOCIN INDOMETHACIN 25MG/5ML SUSPENSION;ORAL Prescription AB Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/10/1985 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
04/28/2021 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018332s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018332Orig1s042ltr.pdf
03/26/2019 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018332s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018332Orig1s040ltr.pdf
05/09/2016 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf
05/09/2016 SUPPL-37 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf
10/16/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
05/09/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
03/31/2009 SUPPL-32 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018332s032lbl.pdf
01/30/2007 SUPPL-30 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-29 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf
03/24/2005 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf
11/26/2001 SUPPL-23 Labeling

Label is not available on this site.
04/28/1998 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
10/31/2001 SUPPL-21 Labeling

Label is not available on this site.
10/24/1994 SUPPL-20 Labeling

Label is not available on this site.
09/13/1994 SUPPL-19 Labeling

Label is not available on this site.
12/30/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
09/26/1994 SUPPL-17 Labeling

Label is not available on this site.
05/25/1989 SUPPL-14 Labeling

Label is not available on this site.
01/06/1989 SUPPL-13 Labeling

Label is not available on this site.
01/09/1989 SUPPL-11 Labeling

Label is not available on this site.
03/10/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
01/06/1989 SUPPL-9 Labeling

Label is not available on this site.
06/03/1988 SUPPL-6 Labeling

Label is not available on this site.
08/15/1986 SUPPL-4 Labeling

Label is not available on this site.
09/19/1986 SUPPL-3 Labeling

Label is not available on this site.
06/04/1986 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/06/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/28/2021 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018332s042lbl.pdf
03/26/2019 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018332s040lbl.pdf
03/26/2019 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018332s040lbl.pdf
05/09/2016 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
05/09/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
05/09/2016 SUPPL-37 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
05/09/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf
03/31/2009 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018332s032lbl.pdf
01/30/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf
01/26/2006 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf

INDOCIN

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOCIN INDOMETHACIN 25MG/5ML SUSPENSION;ORAL Prescription Yes AB 018332 ZYLA
INDOMETHACIN INDOMETHACIN 25MG/5ML SUSPENSION;ORAL Prescription No AB 217883 NOVITIUM PHARMA
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