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 | Bryant Ranch Prepack | 675f999d-46b2-45da-b17e-58cc2ba180b1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b1f1345c-3b7f-4228-b7b7-b9a4648050e5 | 2024-03-28 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | a95cc04c-58e9-487f-8992-ef30df03a3cd | 2024-02-14 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 41c86c02-68c0-4db5-af1a-941b0d2ffe11 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | f5e7503a-b28f-4cd0-a4ee-47bdca88d54b | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | dcfd62c7-1687-4e9b-9ae4-5a44929ac765 | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 22a8cc15-17fb-4c4e-8d2a-de5755ed6031 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 407b62b9-5b32-4bac-a2b0-7df499279248 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | 203088 ANDA203088 |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | db686a0a-9b2a-4017-8bd1-b981da47c2f3 | 2019-01-11 | 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 |
|---|---|---|---|---|---|
| 43353-025 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-106 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-960 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-815 | Duloxetine | DULOXETINE HYDROCHLORIDE | medsource pharmaceuticals | ANDA | Current |
| 50090-2226 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-2226 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-2226 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3028 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3205 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3205 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50090-3205 | Duloxetine | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | ANDA | Current |
| 50436-0747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 50436-0748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Unit Dose Services | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-746 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-747 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-748 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-750 | Duloxetine | DULOXETINE HYDROCHLORIDE | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 53217-130 | DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-505 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-164 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-164 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-165 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | DULOXETINE | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-166 | Duloxetine | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | ANDA | Current |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-042 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-422 | DULOXETINE | DULOXETINE | DIRECT RX | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54331 | ORIG | 2018-05-24 |