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Drugs@FDA: FDA-Approved Drugs

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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INDOCIN INDOMETHACIN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
INDOCIN INDOMETHACIN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016059s101lbl.pdf
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.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-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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