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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202292
Company: NAPO PHARMS INC

Summary Review

Products on NDA 202292

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYTESI	CROFELEMER	125MG	TABLET, DELAYED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/2012	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202292s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202292Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202292Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2024	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202292Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202292Orig1s009ltr.pdf
11/16/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202292s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202292Orig1s007ltr.pdf
03/06/2018	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Proprietary Name Change	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202292Orig1s006ltr.pdf
08/20/2014	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/06/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202292

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2024	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202292Orig1s009lbl.pdf
11/16/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202292s007lbl.pdf
03/06/2018	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf
03/06/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf
03/06/2018	SUPPL-6	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf
12/31/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202292s000lbl.pdf

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