Application 090776

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

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
A090776-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17
A090776-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17
A090776-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090776-001AB
A090776-002AB
A090776-003AB

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 UTC2026-02A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090776-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2013-12-178072bd15b7f6…

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 UTC2026-02A090776-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090776-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090776-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090776-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090776-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090776-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090776-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090776-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090776-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090776-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090776-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090776-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090776-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090776-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090776-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090776-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090776-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090776-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090776-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090776-001AB18072bd15b7f6…

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEHAWAII REPACK, INCb32a39d8-5f1a-4e44-bc46-b65925bde7532026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
DuloxetineDULOXETINEActavis Pharma, Inc.9dab9154-b86f-40dc-a4d1-18e6534dbc782026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
ndc (product): 0228-2890
ndc (product): 0228-2892
ndc (product): 0228-2891
DuloxetineDULOXETINEBryant Ranch Prepackff118c08-2e64-4416-a996-fd9de45d018a2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
DuloxetineDULOXETINEPreferred Phamaceuticals Inc.c5aac428-d929-4688-a9d5-4e9314aa62cc2025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
DuloxetineDULOXETINENuCare Pharmaceuticals,Inc.2d7c2a64-2ce0-f222-e063-6294a90a90562025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx of Tennessee, LLCb33cbab8-1962-cb66-e053-2a95a90a4ae72024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
ndc (product): 80425-0086
DuloxetineDULOXETINEProficient Rx LP3dec1805-9a95-462e-8784-303004d500b12024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
ndc (product): 71205-525
DuloxetineDULOXETINEBryant Ranch Prepack4673ccdd-c86c-4ddc-b462-941897ecfd222024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
DuloxetineDULOXETINEBryant Ranch Prepack726b3c3e-8266-4a8a-a426-899cecd4f87e2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
ndc (product): 63629-8748
DuloxetineDULOXETINEAsclemed USA, Inc.7c755ca3-0855-4b54-80a8-01b85f8e644a2022-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090776
application number: ANDA090776
ndc (product): 76420-236

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
50090-2517DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
50436-2892DuloxetineDuloxetineUnit Dose ServicesANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
70518-1891DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
71205-525DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-525DuloxetineDuloxetineProficient Rx LPANDACurrent
76420-236DuloxetineDuloxetineAsclemed USA, Inc.ANDACurrent
80425-0086CymbaltaDuloxetine HClAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31493ORIG2013-12-20