Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021252
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CANASA MESALAMINE 500MG SUPPOSITORY;RECTAL Discontinued None No No
CANASA MESALAMINE 1GM SUPPOSITORY;RECTAL 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
01/05/2001 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21252ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-252_Canasa.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021252s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021252Orig1s023ltr.pdf
07/30/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/17/2013 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s020ltr.pdf
01/02/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/24/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/03/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/02/2016 SUPPL-14 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021252Orig1s014ltr.pdf
02/06/2013 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021252Orig1s013ltr.pdf
05/23/2008 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021252s009ltr.pdf
06/08/2006 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021252s007LTR.pdf
09/23/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s006ltr.pdf
11/05/2004 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21252s005ltr.pdf
10/14/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21252slr002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/27/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021252s023lbl.pdf
09/02/2016 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021252s014lbl.pdf
12/17/2013 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s020lbl.pdf
02/06/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021252s013lbl.pdf
11/05/2004 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21252s005lbl.pdf
01/05/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21252lbl.pdf

CANASA

SUPPOSITORY;RECTAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CANASA MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription Yes AB 021252 ALLERGAN
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 208362 AMRING PHARMS
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 204354 MYLAN
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 207448 PHARM SOURCING
MESALAMINE MESALAMINE 1GM SUPPOSITORY;RECTAL Prescription No AB 202065 SANDOZ INC

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