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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021411-001STRATTERAATOMOXETINE HYDROCHLORIDEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26
N021411-002STRATTERAATOMOXETINE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-003STRATTERAATOMOXETINE HYDROCHLORIDEEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-004STRATTERAATOMOXETINE HYDROCHLORIDEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-005STRATTERAATOMOXETINE HYDROCHLORIDEEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-006STRATTERAATOMOXETINE HYDROCHLORIDEEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26
N021411-007STRATTERAATOMOXETINE HYDROCHLORIDEEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14
N021411-008STRATTERAATOMOXETINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021411-001STRATTERAEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORAL2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-002STRATTERAEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-003STRATTERAEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-004STRATTERAEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-005STRATTERAEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-006STRATTERAEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2002-11-26a50c72e98297…
2026-08-01 22:54:322026-06N021411-007STRATTERAEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14a50c72e98297…
2026-08-01 22:54:322026-06N021411-008STRATTERAEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2005-02-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StratteraATOMOXETINE HYDROCHLORIDEEli Lilly and Company309de576-c318-404a-bc15-660c2b1876fb2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021411
application number: NDA021411
ndc (product): 0002-3238
ndc (product): 0002-3251
ndc (product): 0002-3239
ndc (product): 0002-3229
ndc (product): 0002-3228
ndc (product): 0002-3250
ndc (product): 0002-3227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 62 matching rows.

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