Application 211310

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASENoNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASENoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211310-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16
A211310-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16
A211310-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211310-001AB
A211310-002AB
A211310-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211310-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-10-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211310-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211310-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211310-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211310-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211310-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211310-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211310-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211310-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211310-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211310-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211310-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211310-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211310-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211310-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211310-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211310-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211310-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211310-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211310-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211310-001AB18072bd15b7f6…

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEYaopharma Co., Ltd.90224073-178d-7ec5-e053-2995a90a20fc2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DULOXETINE HYDROCHLORIDE
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEREMEDYREPACK INC.b9f20917-9529-4c62-bafe-baae7f8d6c772026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDEDULOXETINEAlembic Pharmaceuticals Inc.39453971-766d-45bf-a0fd-4658d72bae722026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDEDULOXETINEAlembic Pharmaceuticals Limited05a744a5-64ef-42d7-a19c-568be5a272d42026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.29eacc40-cbec-4cc9-8556-773346617e852026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
DuloxetineDULOXETINE HYDROCHLORIDEQuallent Pharmaceuticals Health, LLC31362045-201f-45f3-99f2-a5e322a0c30b2025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine HydrochlorideDULOXETINE HYDROCHLORIDEMacleods Pharmaceuticals Limited177ce798-3924-416b-ba37-23dfa911a43b2025-09-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Duloxetine Hydrochloride
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.f535fcd2-a50a-4423-85d9-705fd2d9a4702025-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
CymbaltaDULOXETINE HYDROCHLORIDEEli Lilly and Company2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba2025-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3bae1317-4cc8-4d86-b1b6-15edee733a6d2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.2c233b3f-83de-40c4-9f1d-81f901f894592025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackf66f63c8-51db-4183-a452-78205cf3a2632025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepack276ca221-354c-484d-93d5-0698cb2cfd562025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka23e79b3-7bd3-4b83-beb0-dc23d4830e9e2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka5804a0b-ceae-4ebd-bba0-bfc10e21b90d2025-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepacka891f20f-83ff-4960-81ef-9e74d01a452e2025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackc934cc41-b40b-4c5c-b019-a749eec52d882025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEGolden State Medical Supply, Inc.00628e5e-4c5b-2573-e063-6294a90a0e3b2025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackca36f94c-2215-436f-ada8-7319f4f3e0542025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE
Duloxetine Delayed-ReleaseDULOXETINE HYDROCHLORIDEBryant Ranch Prepackb25c01e0-273a-4f8f-a37e-9b17e5cf378f2025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DULOXETINE HYDROCHLORIDE