Application 075356

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo
003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET;ORALEQ 40MG BASENoNo

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

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
A075356-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30
A075356-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30
A075356-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30
A075356-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075356-001AB
A075356-002AB
A075356-003AB
A075356-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075356-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2003-07-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2003-07-30d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075356-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075356-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075356-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075356-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075356-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075356-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075356-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075356-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075356-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075356-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075356-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075356-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075356-004AB1d06236e962d9…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.8e176ff2-ed3a-4909-94e1-6b9a3581a6212026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 70518-1460
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.beb87e2e-0a8f-43b6-b148-57f0b71915482026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 70518-0993
PAROXETINEPAROXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.e63fe922-b35a-406c-8737-f3f5e6d5a30d2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d3b4536-7900-223c-e063-6294a90a3d602026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEREMEDYREPACK INC.98d4f767-06e3-4d9b-b1ad-4b31f7e361302026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 70518-2871
PAROXETINEPAROXETINE HYDROCHLORIDECardinal Health 107, LLC333dfd07-61f0-4b86-b4b5-b04adf64e49f2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEMajor Pharmaceuticals84b1b1f0-d375-4fda-99af-9487f8ef50c72025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
PAROXETINEPAROXETINE HYDROCHLORIDEApotex Corp.08320ea3-8f93-6f04-5d1c-f69af3eb5a812025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 60505-0101
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC1801246b-02c3-430f-932a-b18cb0d13d1d2018-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 67544-317
PAROXETINEPAROXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCa7128be7-7023-40c4-aa64-29d52145ae312018-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075356
application number: ANDA075356
ndc (product): 67544-492

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 123 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
60505-0101PAROXETINEparoxetine hydrochlorideApotex Corp.ANDACurrent
61919-181PAROXETINE HYDROCHLORIDE ANHYDROUSPAROXETINE HYDROCHLORIDE ANHYDROUSDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-322PAROXETINEPAROXETINEDIRECT RXANDACurrent
61919-512PAROXETINEPAROXETINEDirectRXANDACurrent
61919-512PAROXETINEPAROXETINEDirectRXANDACurrent
63629-3205PAROXETINEparoxetine hydrochlorideBryant Ranch PrepackANDACurrent
64725-0083PAROXETINEparoxetine hydrochlorideTYA PharmaceuticalsANDACurrent
64725-0097PAROXETINEparoxetine hydrochlorideTYA PharmaceuticalsANDACurrent
67544-317PAROXETINEparoxetine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-492PAROXETINEparoxetine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-4283PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4283PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4283PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4283PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4323PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4323PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4323PAROXETINEparoxetine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9694PAROXETINEparoxetine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9694PAROXETINEparoxetine hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0964PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0964PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0993PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1460PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2871PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2871PAROXETINEparoxetine hydrochlorideREMEDYREPACK INC.ANDACurrent
71610-348PAROXETINEparoxetine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23761ORIG2005-08-01
30860ORIG2003-07-31