Documents
Application Sponsors
NDA 018936 | ELI LILLY AND CO | |
Marketing Status
Prescription | 001 |
Prescription | 003 |
Discontinued | 004 |
Prescription | 006 |
Discontinued | 007 |
Discontinued | 008 |
Application Products
001 | CAPSULE;ORAL | EQ 20MG BASE | 1 | PROZAC | FLUOXETINE HYDROCHLORIDE |
003 | CAPSULE;ORAL | EQ 40MG BASE | 1 | PROZAC | FLUOXETINE HYDROCHLORIDE |
004 | CAPSULE;ORAL | EQ 60MG BASE | 0 | PROZAC | FLUOXETINE HYDROCHLORIDE |
006 | CAPSULE;ORAL | EQ 10MG BASE | 1 | PROZAC | FLUOXETINE HYDROCHLORIDE |
007 | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SARAFEM | FLUOXETINE HYDROCHLORIDE |
008 | CAPSULE;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SARAFEM | FLUOXETINE HYDROCHLORIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1987-12-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-05-06 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-09-28 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 4 | AP | 1996-11-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-09-28 | PRIORITY |
LABELING; Labeling | SUPPL | 7 | AP | 1988-06-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1988-10-26 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 1988-11-17 | |
LABELING; Labeling | SUPPL | 11 | AP | 1988-11-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1989-02-17 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 1989-02-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1989-02-08 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 16 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 17 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 18 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 19 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 20 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 21 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 22 | AP | 1990-06-07 | |
LABELING; Labeling | SUPPL | 23 | AP | 1991-04-09 | |
LABELING; Labeling | SUPPL | 24 | AP | 1991-04-09 | |
LABELING; Labeling | SUPPL | 25 | AP | 1992-01-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1992-12-23 | PRIORITY |
LABELING; Labeling | SUPPL | 27 | AP | 1992-01-21 | |
LABELING; Labeling | SUPPL | 28 | AP | 1992-01-21 | |
LABELING; Labeling | SUPPL | 30 | AP | 1992-08-20 | |
LABELING; Labeling | SUPPL | 31 | AP | 1993-08-18 | STANDARD |
LABELING; Labeling | SUPPL | 32 | AP | 1993-03-25 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1995-01-09 | PRIORITY |
LABELING; Labeling | SUPPL | 34 | AP | 1994-07-06 | STANDARD |
LABELING; Labeling | SUPPL | 36 | AP | 1997-03-25 | STANDARD |
LABELING; Labeling | SUPPL | 37 | AP | 1995-03-01 | STANDARD |
LABELING; Labeling | SUPPL | 38 | AP | 1995-09-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1995-03-01 | PRIORITY |
LABELING; Labeling | SUPPL | 40 | AP | 1995-09-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1996-12-30 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1997-09-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1998-04-03 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1998-07-06 | PRIORITY |
LABELING; Labeling | SUPPL | 51 | AP | 1998-03-13 | STANDARD |
LABELING; Labeling | SUPPL | 52 | AP | 1999-10-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1998-05-29 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 1999-06-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1998-10-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1999-02-11 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 58 | AP | 2000-07-06 | STANDARD |
LABELING; Labeling | SUPPL | 59 | AP | 1999-06-16 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2000-11-28 | STANDARD |
EFFICACY; Efficacy | SUPPL | 61 | AP | 2002-07-29 | STANDARD |
LABELING; Labeling | SUPPL | 62 | AP | 2000-11-28 | STANDARD |
LABELING; Labeling | SUPPL | 63 | AP | 2000-11-28 | STANDARD |
EFFICACY; Efficacy | SUPPL | 64 | AP | 2003-01-03 | STANDARD |
EFFICACY; Efficacy | SUPPL | 65 | AP | 2002-07-29 | STANDARD |
EFFICACY; Efficacy | SUPPL | 67 | AP | 2002-06-12 | STANDARD |
LABELING; Labeling | SUPPL | 69 | AP | 2004-08-19 | STANDARD |
LABELING; Labeling | SUPPL | 70 | AP | 2004-09-03 | STANDARD |
LABELING; Labeling | SUPPL | 71 | AP | 2005-12-01 | STANDARD |
LABELING; Labeling | SUPPL | 72 | AP | 2005-02-18 | STANDARD |
LABELING; Labeling | SUPPL | 73 | AP | 2005-12-01 | STANDARD |
LABELING; Labeling | SUPPL | 74 | AP | 2006-04-11 | STANDARD |
LABELING; Labeling | SUPPL | 75 | AP | 2009-03-19 | STANDARD |
LABELING; Labeling | SUPPL | 76 | AP | 2006-09-20 | STANDARD |
EFFICACY; Efficacy | SUPPL | 77 | AP | 2009-03-19 | PRIORITY |
LABELING; Labeling | SUPPL | 78 | AP | 2007-03-15 | STANDARD |
LABELING; Labeling | SUPPL | 81 | AP | 2007-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 82 | AP | 2007-08-02 | STANDARD |
LABELING; Labeling | SUPPL | 83 | AP | 2008-03-09 | STANDARD |
LABELING; Labeling | SUPPL | 84 | AP | 2008-03-21 | STANDARD |
LABELING; Labeling | SUPPL | 86 | AP | 2008-06-26 | STANDARD |
LABELING; Labeling | SUPPL | 88 | AP | 2009-01-30 | 901 REQUIRED |
LABELING; Labeling | SUPPL | 89 | AP | 2009-06-22 | STANDARD Label for SARAFEM |
LABELING; Labeling | SUPPL | 91 | AP | 2011-04-04 | STANDARD |
LABELING; Labeling | SUPPL | 93 | AP | 2011-04-04 | UNKNOWN |
LABELING; Labeling | SUPPL | 95 | AP | 2011-04-04 | UNKNOWN |
LABELING; Labeling | SUPPL | 96 | AP | 2011-06-15 | UNKNOWN |
LABELING; Labeling | SUPPL | 97 | AP | 2013-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 98 | AP | 2013-01-03 | STANDARD |
LABELING; Labeling | SUPPL | 100 | AP | 2013-07-26 | UNKNOWN |
EFFICACY; Efficacy | SUPPL | 101 | AP | 2013-07-26 | STANDARD Label for PROZAC |
EFFICACY; Efficacy | SUPPL | 102 | AP | 2014-10-10 | STANDARD Label for PROZAC |
LABELING; Labeling | SUPPL | 103 | AP | 2017-03-24 | STANDARD Label for PROZAC |
LABELING; Labeling | SUPPL | 105 | AP | 2014-07-18 | 901 REQUIRED Label for PROZAC |
LABELING; Labeling | SUPPL | 106 | AP | 2015-11-24 | 901 REQUIRED |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 107 | AP | 2016-08-01 | PRIORITY |
LABELING; Labeling | SUPPL | 108 | AP | 2017-01-04 | 901 REQUIRED Label for PROZAC |
LABELING; Labeling | SUPPL | 109 | AP | 2020-04-28 | STANDARD |
LABELING; Labeling | SUPPL | 111 | AP | 2021-10-06 | 901 REQUIRED |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 17 | Null | 31 |
SUPPL | 26 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 39 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 46 | Null | 0 |
SUPPL | 49 | Null | 0 |
SUPPL | 50 | Null | 0 |
SUPPL | 53 | Null | 0 |
SUPPL | 54 | Null | 0 |
SUPPL | 56 | Null | 0 |
SUPPL | 57 | Null | 0 |
SUPPL | 64 | Null | 6 |
SUPPL | 77 | Null | 4 |
SUPPL | 91 | Null | 6 |
SUPPL | 93 | Null | 6 |
SUPPL | 95 | Null | 7 |
SUPPL | 96 | Null | 6 |
SUPPL | 97 | Null | 6 |
SUPPL | 98 | Null | 7 |
SUPPL | 100 | Null | 7 |
SUPPL | 101 | Null | 7 |
SUPPL | 102 | Null | 31 |
SUPPL | 103 | Null | 15 |
SUPPL | 105 | Null | 15 |
SUPPL | 106 | Null | 31 |
SUPPL | 107 | Null | 0 |
SUPPL | 108 | Null | 15 |
SUPPL | 109 | Null | 15 |
SUPPL | 111 | Null | 15 |
TE Codes
001 | Prescription | AB1 |
003 | Prescription | AB |
006 | Prescription | AB1 |
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 Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018936s102lbl.pdf\"}]","notes":"Label for PROZAC"},{"actionDate":"07\/18\/2014","submission":"SUPPL-105","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018936s105,021235s024lbl.pdf\"}]","notes":"Label for PROZAC"},{"actionDate":"07\/26\/2013","submission":"SUPPL-101","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018936s100s101,021235s021lbl.pdf\"}]","notes":"Label for PROZAC"},{"actionDate":"07\/26\/2013","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (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
)
)