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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019651
Company: APIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASACOL MESALAMINE 400MG TABLET, DELAYED RELEASE;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
01/31/1992 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/01/2020 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019651Orig1s028ltr.pdf
07/27/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019651s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf
09/16/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
05/27/2015 SUPPL-25 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019651Orig1s025ltr.pdf
10/18/2013 SUPPL-24 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019651Orig1s024ltr.pdf
05/24/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019651s023ltr.pdf
09/14/2009 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019651s020ltr.pdf
04/10/2007 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019651s016LTR.pdf
09/05/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
04/25/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
08/14/2000 SUPPL-11 Labeling

Label is not available on this site.
08/14/2000 SUPPL-10 Labeling

Label is not available on this site.
07/08/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
01/31/1997 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
11/25/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
08/30/1996 SUPPL-6 Labeling

Label is not available on this site.
08/19/1997 SUPPL-5 Efficacy-New Indication Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/asacol_19651s5.html
05/06/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
05/06/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
11/26/1995 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
05/27/1993 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
10/01/2020 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf
10/01/2020 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019651s028lbl.pdf
07/27/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019651s027lbl.pdf
05/27/2015 SUPPL-25 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf
10/18/2013 SUPPL-24 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf
05/24/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf
09/14/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf
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