Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020049
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PENTASA MESALAMINE 250MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
PENTASA MESALAMINE 500MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
05/10/1993 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020049a_052292_biopharmrev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/16/2019 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020049s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020049Orig1s032ltr.pdf
05/30/2018 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020049s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020049Origs031ltr.pdf
07/27/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf
08/22/2017 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s028ltr.pdf
08/05/2015 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020049Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020049Orig1s027.pdf
12/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s026ltr.pdf
07/23/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s025ltr.pdf
06/26/2007 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020049s019ltr.pdf
06/27/2006 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020049s017ltr.pdf
07/08/2004 SUPPL-15 Manufacturing (CMC)-Control Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020049_S015_PENTASA.pdf
09/03/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/12/2000 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/10/1999 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20046S006_Pentasa.cfm
08/05/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/19/1998 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1998 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/1996 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
07/16/2019 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020049s032lbl.pdf
05/30/2018 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020049s031lbl.pdf
08/22/2017 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s028lbl.pdf
07/27/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020049s030lbl.pdf
08/05/2015 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf
12/16/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf
07/23/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf
09/10/1999 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf

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