Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018936
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | AB1 | Yes | No |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB1 | Yes | No |
| SARAFEM | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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SARAFEM | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/29/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-112 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018936Orig1s112,021520Orig1s055ltr.pdf | |
| 10/06/2021 | SUPPL-111 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf | |
| 04/28/2020 | SUPPL-109 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018936Orig1s109ltr.pdf | |
| 01/04/2017 | SUPPL-108 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s108,021235Orig1s026,021520Orig1s047ltr.pdf |
| 08/01/2016 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/2015 | SUPPL-106 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018936Orig1s106ltr.pdf |
| 07/18/2014 | SUPPL-105 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s045,018936Orig1s105,021235Orig1s024ltr.pdf |
| 03/24/2017 | SUPPL-103 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018936Orig1s103,021235Orig1s023,021520Orig1s042ltr.pdf |
| 10/10/2014 | SUPPL-102 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021520Orig1s041,018936Origs102ltr.pdf |
| 07/26/2013 | SUPPL-101 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) |
Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf |
| 07/26/2013 | SUPPL-100 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021520Orig1s039,s037,018936Orig1s100,s101,020592Orig1s063,021086Orig1s041,021235Orig1s021ltr.pdf | |
| 01/03/2013 | SUPPL-98 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf | |
| 01/03/2013 | SUPPL-97 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018936Orig1s097,s098,021235Orig1s019,s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018936Orig1s097.pdf | |
| 06/15/2011 | SUPPL-96 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936Orig1s096,021235Orig1s018ltr.pdf | |
| 04/04/2011 | SUPPL-95 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf | |
| 04/04/2011 | SUPPL-93 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/018936Orig1s093.pdf | |
| 04/04/2011 | SUPPL-91 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018936s091,s093,s095,021235s015,s016,s017ltr.pdf | |
| 06/22/2009 | SUPPL-89 | Labeling |
Label (PDF)
Letter (PDF) |
Label for SARAFEM | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s089ltr.pdf |
| 01/30/2009 | SUPPL-88 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s088,020101s042,021235s014ltr.pdf | |
| 06/26/2008 | SUPPL-86 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s086ltr.pdf | |
| 03/21/2008 | SUPPL-84 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s084,020101s039,021235s011ltr.pdf | |
| 03/09/2008 | SUPPL-83 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018936s083, 020101s038, 021235s010ltr.pdf | |
| 08/02/2007 | SUPPL-82 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf | |
| 08/02/2007 | SUPPL-81 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021427s18,18936s81s82,20101s37,21235s9,21520s1314ltr.pdf | |
| 03/15/2007 | SUPPL-78 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018936s078,021235s008,020101s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/018936Orig1s078.pdf |
| 03/19/2009 | SUPPL-77 | Efficacy-Labeling Change With Clinical Data, REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf | |
| 09/20/2006 | SUPPL-76 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf | |
| 03/19/2009 | SUPPL-75 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018936s077,s075ltr.pdf | |
| 04/11/2006 | SUPPL-74 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf |
| 12/01/2005 | SUPPL-73 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf |
| 02/18/2005 | SUPPL-72 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf |
| 12/01/2005 | SUPPL-71 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf |
| 09/03/2004 | SUPPL-70 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18936s070ltr.pdf |
| 08/19/2004 | SUPPL-69 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21235s002,20974s004,20101s031,18936s069ltr.pdf |
| 06/12/2002 | SUPPL-67 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18936s067ltr.pdf | |
| 07/29/2002 | SUPPL-65 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-64 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18936se5-064ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/18936s064_Prozac.cfm | |
| 11/28/2000 | SUPPL-63 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm |
| 11/28/2000 | SUPPL-62 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm |
| 07/29/2002 | SUPPL-61 | Efficacy-New Indication |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf | |
| 11/28/2000 | SUPPL-60 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018936_S060,S062,S063_ProzacTOC.cfm |
| 06/16/1999 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 07/06/2000 | SUPPL-58 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18936S58LTR.PDF | |
| 02/11/1999 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-54 | Manufacturing (CMC)-Formulation |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936s054_Prozac.cfm |
| 05/29/1998 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1999 | SUPPL-52 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18-936S052_20-101S024_Prozac.cfm |
| 03/13/1998 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 07/06/1998 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/30/1996 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1995 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/1995 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/25/1997 | SUPPL-36 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18936S036_ProzacPulvules.pdf |
| 07/06/1994 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-33 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018936_S033_PROZAC.pdf |
| 03/25/1993 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 08/20/1992 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/21/1992 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 01/21/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/23/1992 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/21/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 04/09/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 04/09/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/07/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/17/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/28/1988 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/1996 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/28/1988 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1988 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-112 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.pdf | |
| 08/18/2023 | SUPPL-112 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018936 s112lbl.pdf | |
| 10/06/2021 | SUPPL-111 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf | |
| 10/06/2021 | SUPPL-111 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf | |
| 04/28/2020 | SUPPL-109 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018936s109lbl.pdf | |
| 03/24/2017 | SUPPL-103 | Labeling-Package Insert | Label (PDF) | Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s103,021235s023lbl.pdf |
| 01/04/2017 | SUPPL-108 | Labeling-Medication Guide | Label (PDF) | Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018936s108lbl.pdf |
| 10/10/2014 | SUPPL-102 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s102lbl.pdf |
| 07/18/2014 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018936s105,021235s024lbl.pdf |
| 07/26/2013 | SUPPL-101 | Efficacy-Pediatric | Label (PDF) | Label for PROZAC | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf |
| 07/26/2013 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s100s101,021235s021lbl.pdf | |
| 01/03/2013 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf | |
| 01/03/2013 | SUPPL-97 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018936s097s098,021235s019s020lbl.pdf | |
| 06/15/2011 | SUPPL-96 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s096,021235s018lbl.pdf | |
| 04/04/2011 | SUPPL-95 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s095lbl.pdf | |
| 04/04/2011 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s093lbl.pdf | |
| 04/04/2011 | SUPPL-91 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf | |
| 06/22/2009 | SUPPL-89 | Labeling | Label (PDF) | Label for SARAFEM | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s089lbl.pdf |
| 03/19/2009 | SUPPL-77 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf | |
| 03/19/2009 | SUPPL-77 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf | |
| 03/19/2009 | SUPPL-75 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s075s077lbl.pdf | |
| 01/30/2009 | SUPPL-88 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018936s088,020101s042,021235s014lbl.pdf | |
| 06/26/2008 | SUPPL-86 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s086lbl.pdf | |
| 03/21/2008 | SUPPL-84 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s084,020101s039,021235s011lbl.pdf | |
| 03/09/2008 | SUPPL-83 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018936s083,020101s038,021235s010lbl.pdf | |
| 08/02/2007 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf | |
| 08/02/2007 | SUPPL-81 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018936s081s082,020101s037,021235s009lbl.pdf | |
| 09/20/2006 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018936s076lbl.pdf | |
| 01/03/2003 | SUPPL-64 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018936s064lbl.pdf | |
| 07/29/2002 | SUPPL-61 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s61s65,20101s27,20974s1lbl.pdf | |
| 06/12/2002 | SUPPL-67 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18936s67lbl.pdf | |
| 07/06/2000 | SUPPL-58 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18936S58LBL.PDF |
PROZAC
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB1 | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075464 | LANDELA PHARM |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075452 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 076001 | TEVA PHARMS USA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | Yes | AB1 | 018936 | ELI LILLY AND CO |
CAPSULE;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075452 | TEVA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018936 | ELI LILLY AND CO |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB1 | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075464 | LANDELA PHARM |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075452 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 076001 | TEVA PHARMS USA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | Yes | AB1 | 018936 | ELI LILLY AND CO |
SARAFEM
There are no Therapeutic Equivalents.