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 43.

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.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-2984e616aacf4f…
2026-08-18 06:07:402026-07N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-001PAXILEQ 10MG BASETABLET / ORALABRLD1992-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-002PAXILEQ 20MG BASETABLET / ORALABRLD1992-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-003PAXILEQ 30MG BASETABLET / ORALABRLD1992-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-004PAXILEQ 50MG BASETABLET / ORAL1992-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-005PAXILEQ 40MG BASETABLET / ORALABRLD, RS1992-12-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020031-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020031-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020031-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020031-005AB184e616aacf4f…
2026-08-18 06:07:402026-07N020031-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020031-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020031-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020031-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020031-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020031-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020031-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020031-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020031-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020031-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020031-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020031-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020031-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020031-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020031-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020031-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020031-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020031-005AB15bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
ParoxetinePAROXETINE HYDROCHLORIDENorthStar Rx LLC118320de-0632-4139-8b13-7428b41da0ac2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.e63fe922-b35a-406c-8737-f3f5e6d5a30d2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDECamber Pharmaceuticals, Inc.26d37a39-1c53-461c-8834-c67fbffcfe992026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d3b4536-7900-223c-e063-6294a90a3d602026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.98d4f767-06e3-4d9b-b1ad-4b31f7e361302026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDECardinal Health 107, LLC333dfd07-61f0-4b86-b4b5-b04adf64e49f2025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
ParoxetinePAROXETINE HYDROCHLORIDEAurobindo Pharma Limited326e8ab0-6886-4749-9544-885b370700512025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
ParoxetinePAROXETINE HYDROCHLORIDEZydus Lifesciences Limited6d5fcdb2-4d84-4b20-87e3-58a43e5675002024-12-03Name fallback
generic name: PAROXETINE HYDROCHLORIDE
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEBryant Ranch Prepackc3c204df-6b7d-42fb-8794-4f38064ed9632024-09-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEOxford Pharmaceuticals, LLC25182b68-8f7a-48e8-9788-6818b0984b292024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
Paroxetine HydrochloridePAROXETINE HYDROCHLORIDEBryant Ranch Prepack5e47c4fb-6070-4cb4-acaa-c6e90199b55c2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
Paroxetine HydrochloridePAROXETINE HYDROCHLORIDELannett Company, Inc.f22886f5-230c-47e4-9dd8-ffb14c8d6ae42023-08-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1801246b-02c3-430f-932a-b18cb0d13d1d2018-11-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCa7128be7-7023-40c4-aa64-29d52145ae312018-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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