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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021252
Company: ABBVIE

Products on NDA 021252

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021252

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
10/24/2023	SUPPL-30	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021252s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021252Orig1s030ltr.pdf
11/16/2022	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021252s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021252Orig1s029ltr.pdf
11/01/2021	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021252s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021252Orig1s028ltr.pdf
10/01/2020	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021252Orig1s025ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert	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

Labels for NDA 021252

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021252s030lbl.pdf
10/24/2023	SUPPL-30	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021252s030lbl.pdf
11/16/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021252s029lbl.pdf
11/01/2021	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021252s028lbl.pdf
11/01/2021	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021252s028lbl.pdf
10/01/2020	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf
10/01/2020	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021252s025lbl.pdf
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

Therapeutic Equivalents for NDA 021252

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	ABBVIE
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	205654	ACTAVIS MID ATLANTIC
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	208362	AMRING PHARMS
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	213377	ANNORA PHARMA
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
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	208953	ZYDUS PHARMS

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