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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022301
Company: SALIX

Summary Review

Products on NDA 022301

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APRISO	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022301

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022301s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301_apriso_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022301s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022301s022lbl.pdf
11/16/2022	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022301s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022301Orig1s021ltr.pdf
11/01/2021	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022301s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022301Orig1s018ltr.pdf
10/01/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022301s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022301Orig1s015ltr.pdf
03/12/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022301s014lbl.pdf
07/27/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022301s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022301Orig1s009ltr.pdf
12/21/2016	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/26/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/25/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022301

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022301s022lbl.pdf
11/16/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022301s021lbl.pdf
11/01/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022301s018lbl.pdf
10/01/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022301s015lbl.pdf
03/12/2019	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022301s014lbl.pdf
07/27/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022301s009lbl.pdf
10/31/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022301lbl.pdf

Therapeutic Equivalents for NDA 022301

APRISO

CAPSULE, EXTENDED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APRISO	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022301	SALIX
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216967	ALEMBIC
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214242	ALKEM LABS LTD
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	217533	AMTA
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214477	AUROBINDO PHARMA LTD
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	207271	MYLAN
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208954	ZYDUS PHARMS

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