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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022526
Company: SPROUT PHARMS

Medication Guide

REMS

Summary Review

Products on NDA 022526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADDYI	FLIBANSERIN	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022526Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2021	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022526s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022526Orig1s010ltr.pdf
10/09/2019	SUPPL-9	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s009ltr.pdf
10/09/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s008ltr.pdf
04/02/2019	SUPPL-7	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s007ltr.pdf
04/11/2019	SUPPL-6		Letter (PDF)	SLC Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/SLC/2019/022526_SLC OrderLtr.pdf
06/16/2017	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022526Orig1s004ltr.pdf
04/08/2016	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022526Orig1s002ltr.pdf

Labels for NDA 022526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022526s010lbl.pdf
09/29/2021	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022526s010lbl.pdf
10/09/2019	SUPPL-9	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf
10/09/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf
08/18/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf

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