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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021860
Company: APIL

Medication Guide

Other Important Information from FDA

Products on NDA 021860

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
SARAFEM	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021860

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021860lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021860s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021860_sarafem_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021860Orig1s015ltr.pdf
01/04/2017	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021860Orig1s011ltr.pdf
12/01/2014	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021860s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021860Orig1s010ltr.pdf
07/05/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf
07/05/2013	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf
07/05/2013	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf
07/05/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf
04/22/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021860s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021860s005ltr.pdf
11/30/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s002ltr.pdf
04/05/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s001ltr.pdf

Labels for NDA 021860

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf
09/20/2021	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021860s015lbl.pdf
01/04/2017	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021860s011lbl.pdf
12/01/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021860s010lbl.pdf
07/05/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf
07/05/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf
07/05/2013	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf
07/05/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf
04/22/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021860s005lbl.pdf
11/30/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s002lbl.pdf
04/05/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s001lbl.pdf
05/19/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021860lbl.pdf

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