Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021860
Company: APIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB1 Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Discontinued None Yes No
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription AB1 Yes Yes
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

SARAFEM

TABLET;ORAL; EQ 10MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB1 206937 TORRENT
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB1 021860 APIL

TABLET;ORAL; EQ 20MG BASE
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription No AB1 206937 TORRENT
SARAFEM FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB1 021860 APIL

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