Application 208706
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | No | No |
| 003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | No | No |
| 004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208706-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | |
| A208706-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | |
| A208706-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 |
| A208706-004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208706-001 | AB |
| A208706-002 | AB |
| A208706-003 | AB |
| A208706-004 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208706-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208706-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208706-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208706-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208706-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208706-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208706-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208706-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-004 | AB | 1 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Duloxetine | DULOXETINE | Aphena Pharma Solutions - Tennessee, LLC | 4121bd3f-2d6d-3bdd-e063-6294a90a3088 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Quallent Pharmaceuticals Health LLC | b3b26383-9924-40f9-b4bb-43e30b70493e | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Ajanta Pharma USA Inc. | 2dde979d-b6f8-41d1-96fb-325c75ea3a74 | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 27241-099 27241-098 27241-097 27241-164 |
| Duloxetine | DULOXETINE | BluePoint Laboratories | 1409fc2b-7252-472f-b719-e56141b36da2 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals, Inc. | 7a7c67be-6800-4ec3-9072-1e0e390a854b | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 68788-7672 |
| Duloxetine | DULOXETINE | Asclemed USA, Inc. | f61bd9f3-cd3d-4c76-a110-0f1dcba610af | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Coupler LLC | 2d942e38-90d4-de39-e063-6294a90a9822 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals, Inc. | 2b61c261-d7f2-4f9d-e063-6294a90acc24 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine HCL DR | DULOXETINE HCL | Advanced Rx Pharmacy of Tennessee, LLC | c4fa1d3b-f136-e14f-e053-2a95a90a6cfb | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine DR | DULOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | b70035d4-5a3f-c5b5-e053-2995a90acac1 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine DR | DULOXETINE | Advanced Rx Pharmacy of Tennessee, LLC | f8c0bc80-b34e-daa8-e053-6394a90a05c2 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | b19ba26f-4711-443e-83cf-5af7bb43a0a0 | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | 3fbdcc34-6166-4843-839c-33fed718ffb2 | 2024-08-07 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | A-S Medication Solutions | 6b1cac95-83e3-4fad-8d60-7a1a9e675eb2 | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | A-S Medication Solutions | b6040e79-0bbd-41a3-ba86-2a360a41864c | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | A-S Medication Solutions | 07a7dd8d-cbf8-4281-8583-d2d98711ed6c | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 50090-5940 |
| Duloxetine | DULOXETINE | Proficient Rx LP | 5410084d-a7db-4da1-a45d-24b91ef50404 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Proficient Rx LP | e36a6919-568a-4d4a-9920-7a7fe4f3441c | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Proficient Rx LP | 39bb9e78-e550-4bf9-ba6a-b4d9c7beaeb7 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 50090-5940 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50436-0198 | Duloxetine | Duloxetine | Unit Dose Services | ANDA | Current |
| 50436-0199 | Duloxetine | Duloxetine | Unit Dose Services | ANDA | Current |
| 51655-237 | Duloxetine | Duloxetine | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1494 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1494 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1561 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1561 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 60760-461 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-461 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-462 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-8051 | Duloxetine | Duloxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8051 | Duloxetine | Duloxetine | Bryant Ranch Prepack | ANDA | Current |
| 68071-4700 | Duloxetine | Duloxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4700 | Duloxetine | Duloxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7935 | Duloxetine | Duloxetine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7935 | Duloxetine | Duloxetine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |