FDA.reportPublic FDA data

Application 077395

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDESUSPENSION;ORALEQ 10MG BASE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077395-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORAL2006-12-05

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077395-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORAL2006-12-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077395-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORAL2006-12-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077395-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORAL2006-12-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077395-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORAL2006-12-05a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEApotex Corp087ff0d3-1761-47ea-a8c1-7c4cb679af972026-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PAROXETINE HYDROCHLORIDE
generic name: PAROXETINE HYDROCHLORIDE
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
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDECamber Pharmaceuticals, Inc.26d37a39-1c53-461c-8834-c67fbffcfe992026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PAROXETINE HYDROCHLORIDE
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 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
brand name: paroxetine hydrochloride
generic name: PAROXETINE HYDROCHLORIDE
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEOxford Pharmaceuticals, LLC25182b68-8f7a-48e8-9788-6818b0984b292024-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: paroxetine hydrochloride
generic name: PAROXETINE HYDROCHLORIDE
Paroxetine HydrochloridePAROXETINE HYDROCHLORIDEBryant Ranch Prepack5e47c4fb-6070-4cb4-acaa-c6e90199b55c2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paroxetine Hydrochloride
generic name: PAROXETINE HYDROCHLORIDE
Paroxetine HydrochloridePAROXETINE HYDROCHLORIDELannett Company, Inc.f22886f5-230c-47e4-9dd8-ffb14c8d6ae42023-08-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Paroxetine Hydrochloride
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.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22601ORIG2011-09-19
44351ORIG2006-12-18