FDA.reportPublic FDA data

Application 018936

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASEYesNo
003PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASEYesYes
004PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 60MG BASENoNo
006PROZACFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASEYesNo
007SARAFEMFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
008SARAFEMFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0777-3104ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3104ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3104ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3104ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3104ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3105ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3105ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3105ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3105ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3105ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3107ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3107ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3107ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3107ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
0777-3107ProzacFluoxetine hydrochlorideDista Products CompanyNDACurrent
70518-2101ProzacFluoxetine hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78575SUPPL 2024-05-29
78425SUPPL 2024-05-08
75234SUPPL 2023-08-22
75197SUPPL 2023-08-22
75196SUPPL 2023-08-22
68970SUPPL2021-10-13
68911SUPPL2021-10-07
62738SUPPL2020-04-29
62737SUPPL2020-04-29
62733SUPPL2020-04-29
47757SUPPL2017-03-29
47720SUPPL2017-03-27
47719SUPPL2017-03-27
46818SUPPL2017-01-13
46698SUPPL2017-01-06
16122SUPPL2015-11-25
20169SUPPL2015-11-18
40831SUPPL2015-11-05
16120SUPPL2014-10-15
11380SUPPL2014-10-15
16121SUPPL2014-07-24
33668SUPPL2014-07-23
20168SUPPL2013-10-21
33667SUPPL2013-07-30
16119SUPPL2013-07-30
11379SUPPL2013-07-30
1146SUPPL2013-07-30
33666SUPPL2013-01-07
33665SUPPL2013-01-07
16118SUPPL2013-01-07
1145SUPPL2013-01-07
33664SUPPL2011-06-16
16117SUPPL2011-06-16
16116SUPPL2011-04-13
1144SUPPL2011-04-13
1143SUPPL2011-04-13
33663SUPPL2011-04-04
33662SUPPL2011-04-04
11378SUPPL2011-04-04
33661SUPPL2009-06-24
16115SUPPL2009-06-24
16110SUPPL2009-03-24
1139SUPPL2009-03-24
33658SUPPL2009-03-20
11372SUPPL2009-03-20
11377SUPPL2009-02-04
16114SUPPL2009-02-03
16113SUPPL2008-07-01
11376SUPPL2008-06-30
11375SUPPL2008-03-24
1142SUPPL2008-03-24
33660SUPPL2008-03-13
16112SUPPL2008-03-12
40828SUPPL2007-12-06
16111SUPPL2007-08-07
1141SUPPL2007-08-07
11374SUPPL2007-08-03
11373SUPPL2007-08-03
1140SUPPL2007-03-23
20166SUPPL2007-02-20
20165SUPPL2007-02-20
20164SUPPL2007-02-20
33659SUPPL2006-09-21
16109SUPPL2006-04-13
16107SUPPL2005-12-05
1138SUPPL2005-12-05
23544ORIG2005-08-01
16108SUPPL2005-02-23
1137SUPPL2004-09-03
1136SUPPL2004-08-25
40830SUPPL2004-08-09
20163SUPPL2004-08-09
40829SUPPL2003-09-25
20167SUPPL2003-09-25
16105SUPPL2003-01-07
11371SUPPL2003-01-07
33656SUPPL2002-07-29
33657SUPPL2002-06-12
16106SUPPL2002-06-12
11370SUPPL2000-07-06
1135SUPPL2000-07-06