Application 076968

Type
ANDA
Sponsor
OXFORD PHARMS

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
A076968-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21
A076968-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21
A076968-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21
A076968-004PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076968-001AB
A076968-002AB
A076968-003AB
A076968-004AB

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 UTC2026-02A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076968-001PAROXETINE HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2010-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-002PAROXETINE HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2010-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-003PAROXETINE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2010-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-004PAROXETINE HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2010-06-21d06236e962d9…

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 UTC2026-02A076968-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076968-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076968-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076968-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076968-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076968-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076968-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076968-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076968-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076968-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076968-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076968-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076968-004AB1d06236e962d9…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEBryant Ranch Prepackc3c204df-6b7d-42fb-8794-4f38064ed9632024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076968
application number: ANDA076968
paroxetine hydrochloridePAROXETINE HYDROCHLORIDEOxford Pharmaceuticals, LLC25182b68-8f7a-48e8-9788-6818b0984b292024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076968
application number: ANDA076968
ndc (product): 69584-672
ndc (product): 69584-673
ndc (product): 69584-671
ndc (product): 69584-674

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69584-671paroxetine hydrochlorideparoxetine hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-672paroxetine hydrochlorideparoxetine hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-673paroxetine hydrochlorideparoxetine hydrochlorideOxford Pharmaceuticals, LLCANDACurrent
69584-674paroxetine hydrochlorideparoxetine hydrochlorideOxford Pharmaceuticals, LLCANDACurrent