Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021860
Company: APIL
Company: APIL
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SARAFEM | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
SARAFEM | FLUOXETINE HYDROCHLORIDE | EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
SARAFEM | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
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 |
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 |