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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021830
Company: APIL

Summary Review

Products on NDA 021830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASACOL HD	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021830

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2008	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/2008/021830lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021830TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021830s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021830Orig1s020ltr.pdf
11/01/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021830s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021830Orig1s019ltr.pdf
10/01/2020	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021830Orig1s016ltr.pdf
05/21/2020	SUPPL-15		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s015lbl.pdf
04/18/2018	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021830s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021830Orig1s012ltr.pdf
07/27/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019651Orig1s0027,204412Orig1s008,021830Orig1s011ltr.pdf
05/05/2016	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf
10/22/2015	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/13/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/18/2013	SUPPL-6	Efficacy-Pediatric	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf
05/24/2010	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf
04/23/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf

Labels for NDA 021830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021830s020lbl.pdf
11/01/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021830s019lbl.pdf
10/01/2020	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf
10/01/2020	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s016lbl.pdf
05/21/2020	SUPPL-15	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021830s015lbl.pdf
04/18/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021830s012lbl.pdf
07/27/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021830s011lbl.pdf
05/05/2016	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf
10/18/2013	SUPPL-6	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf
05/24/2010	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf
04/23/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf
05/29/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf

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