FDA.reportPublic FDA data

Application 020710

Type
NDA
Sponsor
APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAXILPAROXETINE HYDROCHLORIDESUSPENSION;ORALEQ 10MG BASE/5MLYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020710-001PAXILPAROXETINE HYDROCHLORIDEEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1997-06-25

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 22:54:322026-06N020710-001PAXILEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1997-06-25a50c72e98297…

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINE HYDROCHLORIDENorthStar Rx LLC118320de-0632-4139-8b13-7428b41da0ac2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.8e176ff2-ed3a-4909-94e1-6b9a3581a6212026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.beb87e2e-0a8f-43b6-b148-57f0b71915482026-07-02Boxed 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
PAXIL CRPAROXETINE HYDROCHLORIDEApotex Corp483bd97f-c4d0-4e23-aaa8-6334f4471e0c2025-09-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEApotex Corp087ff0d3-1761-47ea-a8c1-7c4cb679af972025-09-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
ParoxetinePAROXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc605c1d23-c97c-4ea4-92d0-fed351de9d2e2025-09-05Boxed 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 HYDROCHLORIDEMajor Pharmaceuticals84b1b1f0-d375-4fda-99af-9487f8ef50c72025-08-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PAROXETINE HYDROCHLORIDE
PAROXETINEPAROXETINE HYDROCHLORIDEApotex Corp.08320ea3-8f93-6f04-5d1c-f69af3eb5a812025-07-24Boxed 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
PAXILPAROXETINE HYDROCHLORIDEApotex Corpef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e2024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PAXIL
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent
60505-0402PAXILparoxetine hydrochlorideApotex CorpNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80480SUPPL 2024-12-03
80459SUPPL 2024-12-02
80458SUPPL 2024-12-02
68844SUPPL2021-10-01
68843SUPPL2021-10-01
68727SUPPL2021-09-23
66804SUPPL2021-03-18
66803SUPPL2021-03-18
66135SUPPL2021-02-09
46814SUPPL2017-01-13
46813SUPPL2017-01-13
46695SUPPL2017-01-06
13262SUPPL2014-07-29
25596SUPPL2014-07-23
13260SUPPL2012-12-31
3161SUPPL2012-12-21
35194SUPPL2012-04-17
3162SUPPL2012-04-12
41603SUPPL2011-12-09
41602SUPPL2011-12-09
41601SUPPL2011-12-09
13259SUPPL2011-07-12
13258SUPPL2011-07-12
3160SUPPL2011-07-12
3156SUPPL2011-07-12
35193SUPPL2011-03-28
35191SUPPL2011-03-28
13261SUPPL2011-03-28
25595SUPPL2011-03-24
3159SUPPL2011-03-24
3158SUPPL2011-03-24
25594SUPPL2010-11-02
35192SUPPL2010-10-28
25592SUPPL2009-11-19
35188SUPPL2009-11-05
35190SUPPL2009-02-04
25593SUPPL2009-02-03
35189SUPPL2008-11-07
3157SUPPL2008-11-03
41600SUPPL2007-09-24
41599SUPPL2007-09-24
20867SUPPL2007-09-24
25590SUPPL2007-08-07
35187SUPPL2007-08-03
25591SUPPL2006-09-20
3155SUPPL2006-09-20
25589SUPPL2006-02-08
3154SUPPL2006-02-08
44067ORIG2005-08-01