NDA 018936

ELI LILLY AND CO

FDA Drug Application

Application #018936

Documents

• Letter: 2000-07-06
• Letter: 2004-08-25
• Letter: 2004-09-03
• Letter: 2005-12-05
• Letter: 2009-03-24
• Letter: 2007-03-23
• Letter: 2007-08-07
• Letter: 2008-03-24
• Letter: 2011-04-13
• Letter: 2011-04-13
• Letter: 2013-01-07
• Letter: 2013-07-30
• Label: 2000-07-06
• Label: 2003-01-07
• Label: 2009-03-20
• Label: 2007-08-03
• Label: 2007-08-03
• Label: 2008-03-24
• Label: 2008-06-30
• Label: 2009-02-04
• Label: 2011-04-04
• Label: 2013-07-30
• Label: 2014-10-15
• Letter: 2003-01-07
• Letter: 2002-06-12
• Letter: 2005-12-05
• Letter: 2005-02-23
• Letter: 2006-04-13
• Letter: 2009-03-24
• Letter: 2007-08-07
• Letter: 2008-03-12
• Letter: 2008-07-01
• Letter: 2009-02-03
• Letter: 2009-06-24
• Letter: 2011-04-13
• Letter: 2011-06-16
• Letter: 2013-01-07
• Letter: 2013-07-30
• Letter: 2014-10-15
• Letter: 2014-07-24
• Letter: 2015-11-25
• Review: 2004-08-09
• Review: 2007-02-20
• Review: 2007-02-20
• Review: 2007-02-20
• Review: 2003-09-25
• Review: 2013-10-21
• Review: 2015-11-18
• Other Important Information from FDA: 2005-08-01
• Label: 2002-07-29
• Label: 2002-06-12
• Label: 2009-03-20
• Label: 2006-09-21
• Label: 2008-03-13
• Label: 2009-06-24
• Label: 2011-04-04
• Label: 2011-04-04
• Label: 2011-06-16
• Label: 2013-01-07
• Label: 2013-01-07
• Label: 2013-07-30
• Label: 2014-07-23
• Review: 2007-12-06
• Review: 2003-09-25
• Review: 2004-08-09
• Review: 2015-11-05
• Label: 2017-01-06
• Letter: 2017-01-13
• Label: 2017-03-27
• Medication Guide: 2017-03-27
• Letter: 2017-03-29
• Letter: 2020-04-29
• Label: 2020-04-29
• Medication Guide: 2020-04-29
• Label: 2021-10-07
• Other: 2021-10-13

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007	CAPSULE;ORAL	EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SARAFEM	FLUOXETINE HYDROCHLORIDE
008	CAPSULE;ORAL	EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SARAFEM	FLUOXETINE HYDROCHLORIDE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
        )

)