FDA.reportPublic FDA data

Application 021411

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL5MGNoNo
002STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL10MGYesNo
003STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL18MGYesNo
004STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL25MGYesNo
005STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL40MGYesNo
006STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL60MGYesYes
007STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL80MGYesNo
008STRATTERAATOMOXETINE HYDROCHLORIDECAPSULE;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-3227StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3227StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3227StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3227StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3228StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3228StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3228StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3228StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3229StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3229StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3229StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3229StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3238StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3238StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3238StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3238StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3239StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3239StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3239StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3239StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3250StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3250StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3250StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3250StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3251StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3251StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3251StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
0002-3251StratteraAtomoxetine hydrochlorideEli Lilly and CompanyNDACurrent
49999-636StratteraAtomoxetineLake Erie Medical DBA Quality Care Products LLCNDACurrent
64725-3228StratteraAtomoxetine hydrochlorideTYA PharmaceuticalsNDACurrent
66993-040AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-040AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-040AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-040AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-041AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-041AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-041AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-042AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-042AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-042AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-042AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-043AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-043AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-043AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-043AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-044AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-044AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-044AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-044AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-045AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-045AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-045AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-045AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-046AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-046AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-046AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-046AtomoxetineAtomoxetine hydrochloridePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68151-4484StratteraAtomoxetine hydrochlorideCarilion Materials ManagementNDACurrent
68151-4485StratteraAtomoxetine hydrochlorideCarilion Materials ManagementNDACurrent
68151-4486StratteraAtomoxetine hydrochlorideCarilion Materials ManagementNDACurrent
68151-4487StratteraAtomoxetine hydrochlorideCarilion Materials ManagementNDACurrent
68151-4488StratteraAtomoxetine hydrochlorideCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69821SUPPL2022-01-07
69820SUPPL2022-01-07
69819SUPPL2022-01-07
61971SUPPL2020-02-26
61970SUPPL2020-02-26
61960SUPPL2020-02-26
48504SUPPL2017-05-24
48486SUPPL2017-05-22
48485SUPPL2017-05-22
15411SUPPL2015-05-29
27717SUPPL2015-05-28
15412SUPPL2015-04-21
5304SUPPL2015-04-20
27716SUPPL2014-02-21
15409SUPPL2014-02-21
5303SUPPL2013-12-09
15410SUPPL2013-12-05
27715SUPPL2013-08-06
5302SUPPL2013-08-06
15408SUPPL2013-08-05
15407SUPPL2013-08-05
36860SUPPL2012-09-12
27714SUPPL2012-08-20
15404SUPPL2012-07-10
5299SUPPL2012-07-09
15406SUPPL2012-06-18
5301SUPPL2012-06-18
5300SUPPL2011-03-10
15405SUPPL2011-03-07
15403SUPPL2010-07-31
27713SUPPL2010-07-30
27712SUPPL2009-06-16
27711SUPPL2009-06-16
36859SUPPL2009-06-04
15402SUPPL2009-06-04
36858SUPPL2008-07-29
36857SUPPL2008-07-29
15401SUPPL2008-07-29
27710SUPPL2008-07-25
5298SUPPL2008-07-25
5297SUPPL2008-07-25
44642SUPPL2008-07-17
5292SUPPL2008-05-09
36856SUPPL2007-10-04
5295SUPPL2007-10-04
21642SUPPL2007-07-06
36855SUPPL2007-05-01
36854SUPPL2007-05-01
36853SUPPL2007-05-01
36852SUPPL2007-05-01
27707SUPPL2007-05-01
27703SUPPL2007-05-01
15400SUPPL2007-05-01
5296SUPPL2007-05-01
5294SUPPL2007-05-01
5293SUPPL2007-05-01
27709SUPPL2006-10-23
15399SUPPL2006-10-23
27708SUPPL2005-11-18
23656ORIG2005-09-30
27704SUPPL2005-05-27
27705SUPPL2005-02-17
27706SUPPL2005-02-03
5291SUPPL2005-02-03
42142ORIG2003-03-07
36851SUPPL2003-01-17
27702SUPPL2003-01-17
15398ORIG2002-11-26
5290ORIG2002-11-26