Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020049
Company: TAKEDA PHARMS USA

Products on NDA 20049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTASA	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
PENTASA	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020049

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/14/2026	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020049s044lbl.pdf
07/30/2024	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020049s041lbl.pdf
10/24/2023	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020049s040lbl.pdf
11/16/2022	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020049s038lbl.pdf
11/01/2021	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s036lbl.pdf
05/25/2021	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020049s035lbl.pdf
10/29/2020	SUPPL-34	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049Orig1s034lbl.pdf
10/01/2020	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020049s033lbl.pdf
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