Application 077873

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077873-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29
A077873-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077873-001AB
A077873-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077873-001PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077873-002PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2007-06-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077873-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077873-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077873-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077873-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077873-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077873-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077873-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077873-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077873-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077873-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077873-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077873-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077873-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077873-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077873-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077873-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077873-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077873-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077873-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077873-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077873-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077873-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077873-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077873-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077873-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077873-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077873-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077873-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077873-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077873-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077873-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077873-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077873-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077873-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077873-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077873-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077873-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077873-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077873-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077873-002AB1782e0a99824c…

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 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
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 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
brand name: PAROXETINE HYDROCHLORIDE
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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2003Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-2004Paroxetine Hydrochlorideparoxetine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22615ORIG2013-01-28
44365ORIG2007-07-05
31295ORIG2007-07-05