Application 203088
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
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 |
|---|---|---|---|---|---|---|---|
| A203088-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | |
| A203088-004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203088-001 | AB |
| A203088-002 | AB |
| A203088-003 | AB |
| A203088-004 | 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 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2018-05-18 | 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 | A203088-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203088-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203088-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203088-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203088-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203088-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203088-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203088-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203088-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203088-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203088-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203088-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203088-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203088-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203088-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203088-004 | 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 Delayed-Release | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 00628e5e-4c5b-2573-e063-6294a90a0e3b | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | b9f20917-9529-4c62-bafe-baae7f8d6c77 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 70518-0122 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 29eacc40-cbec-4cc9-8556-773346617e85 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 68788-7897 |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Quallent Pharmaceuticals Health, LLC | 31362045-201f-45f3-99f2-a5e322a0c30b | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 82009-029 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3bae1317-4cc8-4d86-b1b6-15edee733a6d | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | f66f63c8-51db-4183-a452-78205cf3a263 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 276ca221-354c-484d-93d5-0698cb2cfd56 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a23e79b3-7bd3-4b83-beb0-dc23d4830e9e | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a5804a0b-ceae-4ebd-bba0-bfc10e21b90d | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a891f20f-83ff-4960-81ef-9e74d01a452e | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 71335-0165 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | c934cc41-b40b-4c5c-b019-a749eec52d88 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 63629-9187 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca36f94c-2215-436f-ada8-7319f4f3e054 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 63629-1991 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | b25c01e0-273a-4f8f-a37e-9b17e5cf378f | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 63629-1990 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | caef6f50-1571-4ec7-8f8c-42b924d323ee | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | df61b895-c358-827b-e053-2995a90a9b60 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 68071-2711 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 41876761-9d5b-4190-a200-6a822c54582e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 71335-0392 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 0c82422a-d493-4dda-8626-0d9baa25db8c | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 71335-0509 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca376622-d32c-4e6e-8af4-8e24a8d20d83 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 63629-1992 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | be33f3cb-6fd1-4377-816e-84bd49370e9e | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
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 |
|---|---|---|---|---|---|
| 61919-422 | DULOXETINE | DULOXETINE | Direct_Rx | ANDA | Current |
| 61919-422 | DULOXETINE | DULOXETINE | Direct_Rx | ANDA | Current |
| 61919-422 | DULOXETINE | DULOXETINE | Direct_Rx | ANDA | Current |
| 61919-422 | DULOXETINE | DULOXETINE | Direct_Rx | ANDA | Current |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-482 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 62034-021 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Blenheim Pharmacal, Inc. | ANDA | Current |
| 62034-029 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Blenheim Pharmacal, Inc. | ANDA | Current |
| 63187-702 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-702 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-702 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-720 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-720 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-735 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-735 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63187-735 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | ANDA | Current |
| 63629-1990 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1990 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1990 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1991 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1991 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1991 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1992 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1992 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-1992 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-2063 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-2063 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-2063 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-9187 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 64725-0747 | DULOXETINE | DULOXETINE HYDROCHLORIDE | TYA Pharmaceuticals | ANDA | Current |
| 67046-679 | Duloxetine | DULOXETINE HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-691 | Duloxetine | DULOXETINE HYDROCHLORIDE | Contract Pharmacy Services-PA | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68001-368 | Duloxetine | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | ANDA | Current |
| 68071-2711 | Duloxetine | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5104 | Duloxetine | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5104 | Duloxetine | DULOXETINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6380 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6380 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7399 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7399 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7897 | Duloxetine | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7897 | Duloxetine | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9301 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9301 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9301 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9301 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0122 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0122 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0122 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0343 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0343 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0343 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0343 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-0343 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1802 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1802 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1802 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1802 | Duloxetine | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70934-729 | Duloxetine | DULOXETINE HYDROCHLORIDE | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-0165 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0165 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0165 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0392 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0392 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0392 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0392 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0509 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71335-0509 | Duloxetine | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 71610-218 | Duloxetine | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71800-011 | Duloxetine Hydrochloride Delayed Release | Duloxetine Hydrochloride | Innovida Pharmaceutique Corporation | ANDA | Current |
| 82009-029 | Duloxetine | DULOXETINE HYDROCHLORIDE | Quallent Pharmaceuticals Health, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54331 | ORIG | 2018-05-24 |