ELI LILLY AND CO FDA Approval NDA 018936

NDA 018936

ELI LILLY AND CO

FDA Drug Application

Application #018936

Documents

Letter2000-07-06
Letter2004-08-25
Letter2004-09-03
Letter2005-12-05
Letter2009-03-24
Letter2007-03-23
Letter2007-08-07
Letter2008-03-24
Letter2011-04-13
Letter2011-04-13
Letter2013-01-07
Letter2013-07-30
Label2000-07-06
Label2003-01-07
Label2009-03-20
Label2007-08-03
Label2007-08-03
Label2008-03-24
Label2008-06-30
Label2009-02-04
Label2011-04-04
Label2013-07-30
Label2014-10-15
Letter2003-01-07
Letter2002-06-12
Letter2005-12-05
Letter2005-02-23
Letter2006-04-13
Letter2009-03-24
Letter2007-08-07
Letter2008-03-12
Letter2008-07-01
Letter2009-02-03
Letter2009-06-24
Letter2011-04-13
Letter2011-06-16
Letter2013-01-07
Letter2013-07-30
Letter2014-10-15
Letter2014-07-24
Letter2015-11-25
Review2004-08-09
Review2007-02-20
Review2007-02-20
Review2007-02-20
Review2003-09-25
Review2013-10-21
Review2015-11-18
Other Important Information from FDA2005-08-01
Label2002-07-29
Label2002-06-12
Label2009-03-20
Label2006-09-21
Label2008-03-13
Label2009-06-24
Label2011-04-04
Label2011-04-04
Label2011-06-16
Label2013-01-07
Label2013-01-07
Label2013-07-30
Label2014-07-23
Review2007-12-06
Review2003-09-25
Review2004-08-09
Review2015-11-05
Label2017-01-06
Letter2017-01-13
Label2017-03-27
Medication Guide2017-03-27
Letter2017-03-29
Letter2020-04-29
Label2020-04-29
Medication Guide2020-04-29
Label2021-10-07
Other2021-10-13

Application Sponsors

NDA 018936ELI LILLY AND CO

Marketing Status

Prescription001
Prescription003
Discontinued004
Prescription006
Discontinued007
Discontinued008

Application Products

001CAPSULE;ORALEQ 20MG BASE1PROZACFLUOXETINE HYDROCHLORIDE
003CAPSULE;ORALEQ 40MG BASE1PROZACFLUOXETINE HYDROCHLORIDE
004CAPSULE;ORALEQ 60MG BASE0PROZACFLUOXETINE HYDROCHLORIDE
006CAPSULE;ORALEQ 10MG BASE1PROZACFLUOXETINE HYDROCHLORIDE
007CAPSULE;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1SARAFEMFLUOXETINE HYDROCHLORIDE
008CAPSULE;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1SARAFEMFLUOXETINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1987-12-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-05-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1988-09-28PRIORITY
EFFICACY; EfficacySUPPL4AP1996-11-21
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1988-09-28PRIORITY
LABELING; LabelingSUPPL7AP1988-06-22
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1988-10-26PRIORITY
LABELING; LabelingSUPPL9AP1988-11-17
LABELING; LabelingSUPPL11AP1988-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1989-02-17PRIORITY
LABELING; LabelingSUPPL13AP1989-02-16
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1989-02-08PRIORITY
LABELING; LabelingSUPPL15AP1990-06-07
LABELING; LabelingSUPPL16AP1990-06-07
LABELING; LabelingSUPPL17AP1990-06-07
LABELING; LabelingSUPPL18AP1990-06-07
LABELING; LabelingSUPPL19AP1990-06-07
LABELING; LabelingSUPPL20AP1990-06-07
LABELING; LabelingSUPPL21AP1990-06-07
LABELING; LabelingSUPPL22AP1990-06-07
LABELING; LabelingSUPPL23AP1991-04-09
LABELING; LabelingSUPPL24AP1991-04-09
LABELING; LabelingSUPPL25AP1992-01-21
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1992-12-23PRIORITY
LABELING; LabelingSUPPL27AP1992-01-21
LABELING; LabelingSUPPL28AP1992-01-21
LABELING; LabelingSUPPL30AP1992-08-20
LABELING; LabelingSUPPL31AP1993-08-18STANDARD
LABELING; LabelingSUPPL32AP1993-03-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP1995-01-09PRIORITY
LABELING; LabelingSUPPL34AP1994-07-06STANDARD
LABELING; LabelingSUPPL36AP1997-03-25STANDARD
LABELING; LabelingSUPPL37AP1995-03-01STANDARD
LABELING; LabelingSUPPL38AP1995-09-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP1995-03-01PRIORITY
LABELING; LabelingSUPPL40AP1995-09-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP1996-12-30PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL46AP1997-09-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL49AP1998-04-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL50AP1998-07-06PRIORITY
LABELING; LabelingSUPPL51AP1998-03-13STANDARD
LABELING; LabelingSUPPL52AP1999-10-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL53AP1998-05-29PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL54AP1999-06-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL56AP1998-10-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL57AP1999-02-11PRIORITY
EFFICACY; EfficacySUPPL58AP2000-07-06STANDARD
LABELING; LabelingSUPPL59AP1999-06-16STANDARD
LABELING; LabelingSUPPL60AP2000-11-28STANDARD
EFFICACY; EfficacySUPPL61AP2002-07-29STANDARD
LABELING; LabelingSUPPL62AP2000-11-28STANDARD
LABELING; LabelingSUPPL63AP2000-11-28STANDARD
EFFICACY; EfficacySUPPL64AP2003-01-03STANDARD
EFFICACY; EfficacySUPPL65AP2002-07-29STANDARD
EFFICACY; EfficacySUPPL67AP2002-06-12STANDARD
LABELING; LabelingSUPPL69AP2004-08-19STANDARD
LABELING; LabelingSUPPL70AP2004-09-03STANDARD
LABELING; LabelingSUPPL71AP2005-12-01STANDARD
LABELING; LabelingSUPPL72AP2005-02-18STANDARD
LABELING; LabelingSUPPL73AP2005-12-01STANDARD
LABELING; LabelingSUPPL74AP2006-04-11STANDARD
LABELING; LabelingSUPPL75AP2009-03-19STANDARD
LABELING; LabelingSUPPL76AP2006-09-20STANDARD
EFFICACY; EfficacySUPPL77AP2009-03-19PRIORITY
LABELING; LabelingSUPPL78AP2007-03-15STANDARD
LABELING; LabelingSUPPL81AP2007-08-02STANDARD
LABELING; LabelingSUPPL82AP2007-08-02STANDARD
LABELING; LabelingSUPPL83AP2008-03-09STANDARD
LABELING; LabelingSUPPL84AP2008-03-21STANDARD
LABELING; LabelingSUPPL86AP2008-06-26STANDARD
LABELING; LabelingSUPPL88AP2009-01-30901 REQUIRED
LABELING; LabelingSUPPL89AP2009-06-22STANDARD Label for SARAFEM
LABELING; LabelingSUPPL91AP2011-04-04STANDARD
LABELING; LabelingSUPPL93AP2011-04-04UNKNOWN
LABELING; LabelingSUPPL95AP2011-04-04UNKNOWN
LABELING; LabelingSUPPL96AP2011-06-15UNKNOWN
LABELING; LabelingSUPPL97AP2013-01-03STANDARD
LABELING; LabelingSUPPL98AP2013-01-03STANDARD
LABELING; LabelingSUPPL100AP2013-07-26UNKNOWN
EFFICACY; EfficacySUPPL101AP2013-07-26STANDARD Label for PROZAC
EFFICACY; EfficacySUPPL102AP2014-10-10STANDARD Label for PROZAC
LABELING; LabelingSUPPL103AP2017-03-24STANDARD Label for PROZAC
LABELING; LabelingSUPPL105AP2014-07-18901 REQUIRED Label for PROZAC
LABELING; LabelingSUPPL106AP2015-11-24901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL107AP2016-08-01PRIORITY
LABELING; LabelingSUPPL108AP2017-01-04901 REQUIRED Label for PROZAC
LABELING; LabelingSUPPL109AP2020-04-28STANDARD
LABELING; LabelingSUPPL111AP2021-10-06901 REQUIRED

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL6Null0
SUPPL8Null0
SUPPL12Null0
SUPPL14Null0
SUPPL17Null31
SUPPL26Null0
SUPPL33Null0
SUPPL39Null0
SUPPL43Null0
SUPPL46Null0
SUPPL49Null0
SUPPL50Null0
SUPPL53Null0
SUPPL54Null0
SUPPL56Null0
SUPPL57Null0
SUPPL64Null6
SUPPL77Null4
SUPPL91Null6
SUPPL93Null6
SUPPL95Null7
SUPPL96Null6
SUPPL97Null6
SUPPL98Null7
SUPPL100Null7
SUPPL101Null7
SUPPL102Null31
SUPPL103Null15
SUPPL105Null15
SUPPL106Null31
SUPPL107Null0
SUPPL108Null15
SUPPL109Null15
SUPPL111Null15

TE Codes

001PrescriptionAB1
003PrescriptionAB
006PrescriptionAB1

CDER Filings

ELI LILLY AND CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18936
            [companyName] => ELI LILLY AND CO
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/018936s109lbl.pdf#page=26"]
            [products] => [{"drugName":"PROZAC","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"PROZAC","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"PROZAC","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 60MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROZAC","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"SARAFEM","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SARAFEM","activeIngredients":"FLUOXETINE HYDROCHLORIDE","strength":"EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2020","submission":"SUPPL-109","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018936s109lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2017","submission":"SUPPL-103","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018936s103,021235s023lbl.pdf\"}]","notes":"Label for PROZAC"},{"actionDate":"01\/04\/2017","submission":"SUPPL-108","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018936s108lbl.pdf\"}]","notes":"Label for PROZAC"},{"actionDate":"10\/10\/2014","submission":"SUPPL-102","supplementCategories":"Efficacy-Labeling Change With Clinical 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018936s100s101,021235s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2013","submission":"SUPPL-98","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018936s097s098,021235s019s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2013","submission":"SUPPL-97","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018936s097s098,021235s019s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2011","submission":"SUPPL-96","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018936s096,021235s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2011","submission":"SUPPL-95","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018936s095lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2011","submission":"SUPPL-93","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018936s093lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2011","submission":"SUPPL-91","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018936s091lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2009","submission":"SUPPL-89","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018936s089lbl.pdf\"}]","notes":"Label for SARAFEM"},{"actionDate":"03\/19\/2009","submission":"SUPPL-77","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018936s075s077lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2009","submission":"SUPPL-77","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018936s075s077lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2009","submission":"SUPPL-75","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018936s075s077lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2009","submission":"SUPPL-88","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018936s088,020101s042,021235s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2008","submission":"SUPPL-86","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018936s086lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2008","submission":"SUPPL-84","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018936s084,020101s039,021235s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2008","submission":"SUPPL-83","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018936s083,020101s038,021235s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2007","submission":"SUPPL-82","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018936s081s082,020101s037,021235s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2007","submission":"SUPPL-81","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018936s081s082,020101s037,021235s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2006","submission":"SUPPL-76","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018936s076lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2003","submission":"SUPPL-64","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/018936s064lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2002","submission":"SUPPL-61","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18936s61s65,20101s27,20974s1lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2002","submission":"SUPPL-67","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18936s67lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2000","submission":"SUPPL-58","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/18936S58LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROZAC","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROZAC","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"PROZAC","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 60MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROZAC","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SARAFEM","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SARAFEM","submission":"FLUOXETINE HYDROCHLORIDE","actionType":"EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-04-28
        )

)

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