Application 208706

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208706-001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06
A208706-002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06
A208706-003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-06
A208706-004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208706-001AB
A208706-002AB
A208706-003AB
A208706-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06c2088c7a36db…
2026-10-15 13:18:302026-09A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06c2088c7a36db…
2026-10-15 13:18:302026-09A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-06c2088c7a36db…
2026-10-15 13:18:302026-09A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11c2088c7a36db…
2026-09-14 22:38:342026-08A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0684e616aacf4f…
2026-09-14 22:38:342026-08A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0684e616aacf4f…
2026-09-14 22:38:342026-08A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-0684e616aacf4f…
2026-09-14 22:38:342026-08A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-1184e616aacf4f…
2026-08-18 06:07:402026-07A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-06caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALABRS2017-01-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-001DULOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-002DULOXETINE HYDROCHLORIDEEQ 30MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-003DULOXETINE HYDROCHLORIDEEQ 60MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-01-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-004DULOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-03-112680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A208706-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208706-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208706-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A208706-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A208706-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208706-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208706-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208706-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A208706-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208706-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208706-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208706-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208706-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208706-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208706-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208706-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208706-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208706-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208706-004AB12680178bc6a6…

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 2 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DuloxetineDULOXETINEQuallent Pharmaceuticals Health LLCb3b26383-9924-40f9-b4bb-43e30b70493e2025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEAjanta Pharma USA Inc.2dde979d-b6f8-41d1-96fb-325c75ea3a742025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEBluePoint Laboratories1409fc2b-7252-472f-b719-e56141b36da22025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEPreferred Pharmaceuticals, Inc.7a7c67be-6800-4ec3-9072-1e0e390a854b2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEAsclemed USA, Inc.f61bd9f3-cd3d-4c76-a110-0f1dcba610af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINECoupler LLC2d942e38-90d4-de39-e063-6294a90a98222025-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINENuCare Pharmaceuticals, Inc.2b61c261-d7f2-4f9d-e063-6294a90acc242025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
Duloxetine HCL DRDULOXETINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc4fa1d3b-f136-e14f-e053-2a95a90a6cfb2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 80425-0146
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCb70035d4-5a3f-c5b5-e053-2995a90acac12024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 80425-0119
Duloxetine DRDULOXETINEAdvanced Rx Pharmacy of Tennessee, LLCf8c0bc80-b34e-daa8-e053-6394a90a05c22024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEBryant Ranch Prepackb19ba26f-4711-443e-83cf-5af7bb43a0a02024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 71335-0402
DuloxetineDULOXETINEBryant Ranch Prepack3fbdcc34-6166-4843-839c-33fed718ffb22024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 71335-2017
DuloxetineDULOXETINEA-S Medication Solutions6b1cac95-83e3-4fad-8d60-7a1a9e675eb22023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEA-S Medication Solutionsb6040e79-0bbd-41a3-ba86-2a360a41864c2023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEA-S Medication Solutions07a7dd8d-cbf8-4281-8583-d2d98711ed6c2023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
DuloxetineDULOXETINEProficient Rx LP5410084d-a7db-4da1-a45d-24b91ef504042022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 71205-005
DuloxetineDULOXETINEProficient Rx LPe36a6919-568a-4d4a-9920-7a7fe4f3441c2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 71205-358
DuloxetineDULOXETINEProficient Rx LP39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb72022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208706
application number: ANDA208706
ndc (product): 71205-602

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 110 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1139DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1139DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2630DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2630DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2630DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2630DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-3287DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-3287DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
71205-005DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-005DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-005DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-005DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-358DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-358DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-602DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-602DuloxetineDuloxetineProficient Rx LPANDACurrent
71335-0402DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71335-0402DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71335-0402DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71335-2017DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71610-403DuloxetineDuloxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0119CymbaltaDuloxetine 60mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0119DuloxetineDuloxetineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0119DuloxetineDuloxetineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0119DuloxetineDuloxetineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0146CymbaltaDuloxetine 30mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0146Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0146Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0146Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0146Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent