Application 020885

Type
NDA
Sponsor
APOTEX TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAXILPAROXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002PAXILPAROXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003PAXILPAROXETINE HYDROCHLORIDECAPSULE;ORALEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004PAXILPAROXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020885-001PAXILPAROXETINE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09
N020885-002PAXILPAROXETINE HYDROCHLORIDEEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09
N020885-003PAXILPAROXETINE HYDROCHLORIDEEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09
N020885-004PAXILPAROXETINE HYDROCHLORIDEEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020885-001PAXILEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020885-002PAXILEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020885-003PAXILEQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020885-004PAXILEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1998-10-09d8e5a09893c0…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020885-00160639272019-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-0016063927*PED2019-10-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-00260639272019-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-0026063927*PED2019-10-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-00360639272019-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-0036063927*PED2019-10-23Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-00460639272019-04-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020885-0046063927*PED2019-10-23Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020885-00160639272019-04-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-0016063927*PED2019-10-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-00260639272019-04-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-0026063927*PED2019-10-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-00360639272019-04-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-0036063927*PED2019-10-23Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-00460639272019-04-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020885-0046063927*PED2019-10-23Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020885-00160639272019-04-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-0016063927*PED2019-10-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-00260639272019-04-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-0026063927*PED2019-10-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-00360639272019-04-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-0036063927*PED2019-10-23Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-00460639272019-04-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020885-0046063927*PED2019-10-23Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020885-00160639272019-04-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-0016063927*PED2019-10-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-00260639272019-04-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-0026063927*PED2019-10-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-00360639272019-04-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-0036063927*PED2019-10-23Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-00460639272019-04-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020885-0046063927*PED2019-10-23Pediatric extensionea99ee380514…

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 2 · 22 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 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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41783SUPPL2011-12-09
41782SUPPL2011-12-09
21042SUPPL2011-12-09
23607ORIG2005-08-01
21041ORIG1998-10-09
3654ORIG1998-10-09