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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213426
Company: KOWA PHARMS

Medication Guide

REMS

Products on NDA 213426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEGLENTIS	CELECOXIB; TRAMADOL HYDROCHLORIDE	56MG;44MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2021	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213426Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213426Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213426Orig1s004ltr.pdf
11/21/2024	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213426s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213426Orig1s003ltr.pdf
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213426s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213426Orig1s002ltr.pdf
01/06/2023	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213426Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213426Orig1s001ltr.pdf

Labels for NDA 213426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213426s003lbl.pdf
12/15/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213426s002lbl.pdf
01/06/2023	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213426Orig1s001lbl.pdf
10/15/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213426s000lbl.pdf

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