FDA.reportPublic FDA data

Application 020031

Type
NDA
Sponsor
APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAXILPAROXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesNo
002PAXILPAROXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASEYesNo
003PAXILPAROXETINE HYDROCHLORIDETABLET;ORALEQ 30MG BASEYesNo
004PAXILPAROXETINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
005PAXILPAROXETINE HYDROCHLORIDETABLET;ORALEQ 40MG BASEYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020031-001PAXILPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALABRLD1992-12-29
N020031-002PAXILPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALABRLD1992-12-29
N020031-003PAXILPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALABRLD1992-12-29
N020031-004PAXILPAROXETINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL1992-12-29
N020031-005PAXILPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020031-001AB
N020031-002AB
N020031-003AB
N020031-005AB

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 22:54:322026-06N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29a50c72e98297…
2026-08-01 22:54:322026-06N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020031-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N020031-005AB1a50c72e98297…

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
PAXILPAROXETINE HYDROCHLORIDEApotex Corpef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020031
application number: NDA020031
ndc (product): 60505-4520
ndc (product): 60505-4518
ndc (product): 60505-4517
ndc (product): 60505-4519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3663PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3663PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3663PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3664PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3664PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3664PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3665PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3665PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3665PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3666PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3666PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3666PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-3666PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4517PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4517PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4517PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4517PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4517PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4518PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4518PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4518PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4518PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4518PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4519PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4519PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4519PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4519PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4519PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4520PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4520PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4520PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4520PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-4520PAXILparoxetine hydrochlorideApotex CorpNDACurrent
70518-2500PAXILparoxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2636PAXILparoxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2636PAXILparoxetine hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2636PAXILparoxetine hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80479SUPPL 2024-12-03
80457SUPPL 2024-12-02
80456SUPPL 2024-12-02
76590SUPPL 2023-11-16
68842SUPPL2021-10-01
68841SUPPL2021-10-01
69745SUPPL2021-09-30
68726SUPPL2021-09-23
66182SUPPL2021-02-11
66181SUPPL2021-02-11
66134SUPPL2021-02-09
46812SUPPL2017-01-13
46811SUPPL2017-01-13
46694SUPPL2017-01-06
12148SUPPL2014-07-29
1926SUPPL2014-07-23
41125SUPPL2014-01-16
34190SUPPL2012-12-31
1925SUPPL2012-12-21
34191SUPPL2012-04-17
21056SUPPL2012-04-12
34189SUPPL2011-07-12
34186SUPPL2011-07-12
1924SUPPL2011-07-12
1919SUPPL2011-07-12
34192SUPPL2011-03-28
12147SUPPL2011-03-28
12146SUPPL2011-03-28
21057SUPPL2011-03-24
1923SUPPL2011-03-24
1921SUPPL2011-03-24
1922SUPPL2010-11-02
34188SUPPL2010-10-28
1920SUPPL2009-11-19
12144SUPPL2009-11-05
34187SUPPL2009-02-04
21055SUPPL2009-02-03
12145SUPPL2008-11-07
21054SUPPL2008-11-03
1918SUPPL2007-08-07
12143SUPPL2007-08-03
41124SUPPL2007-07-09
41123SUPPL2007-07-09
41122SUPPL2007-07-09
20454SUPPL2007-07-09
20453SUPPL2007-07-09
19951SUPPL2006-09-25
19950SUPPL2006-09-25
19947SUPPL2006-09-25
19946SUPPL2006-03-23
19949SUPPL2006-02-08
19948SUPPL2006-02-08
1917SUPPL2006-02-08
44042ORIG2005-08-16
1915SUPPL2005-07-15
19945SUPPL2005-01-13
12142SUPPL2005-01-13
20455SUPPL2004-09-15
20452SUPPL2004-06-29
1916SUPPL2004-05-27
19944SUPPL2004-04-20
19943SUPPL2004-04-20
34184SUPPL2003-04-24
19942SUPPL2002-10-02
34185SUPPL2001-12-14
19941SUPPL2001-12-14
19940SUPPL2001-04-13
12141SUPPL2001-04-13
1914SUPPL1999-05-11
53124ORIG1900-01-01
53123ORIG1900-01-01
53122ORIG1900-01-01
53121ORIG1900-01-01