Application 202045
- Type
- ANDA
- Sponsor
- APOTEX
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202045-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | ||
| A202045-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | ||
| A202045-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202045-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202045-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202045-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2014-06-11 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202045-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202045-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202045-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202045-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202045-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202045-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202045-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202045-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202045-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202045-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202045-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202045-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202045-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202045-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202045-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202045-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202045-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202045-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202045-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202045-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202045-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202045-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202045-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A202045-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202045-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202045-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A202045-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202045-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202045-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A202045-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202045-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202045-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A202045-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202045-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202045-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A202045-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202045-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202045-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A202045-003 | AB | 1 | ea99ee380514… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202045-001 | AB | 1 | a72a2bbeb626… |
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 HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | 90224073-178d-7ec5-e053-2995a90a20fc | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | b9f20917-9529-4c62-bafe-baae7f8d6c77 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE | Alembic Pharmaceuticals Inc. | 39453971-766d-45bf-a0fd-4658d72bae72 | 2026-05-06 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| DULOXETINE HYDROCHLORIDE | DULOXETINE | Alembic Pharmaceuticals Limited | 05a744a5-64ef-42d7-a19c-568be5a272d4 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 29eacc40-cbec-4cc9-8556-773346617e85 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Quallent Pharmaceuticals Health, LLC | 31362045-201f-45f3-99f2-a5e322a0c30b | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Hydrochloride | DULOXETINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 177ce798-3924-416b-ba37-23dfa911a43b | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | f535fcd2-a50a-4423-85d9-705fd2d9a470 | 2025-07-22 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Cymbalta | DULOXETINE HYDROCHLORIDE | Eli Lilly and Company | 2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba | 2025-07-21 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 3bae1317-4cc8-4d86-b1b6-15edee733a6d | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2c233b3f-83de-40c4-9f1d-81f901f89459 | 2025-04-04 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | f66f63c8-51db-4183-a452-78205cf3a263 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 276ca221-354c-484d-93d5-0698cb2cfd56 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a23e79b3-7bd3-4b83-beb0-dc23d4830e9e | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a5804a0b-ceae-4ebd-bba0-bfc10e21b90d | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | a891f20f-83ff-4960-81ef-9e74d01a452e | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | c934cc41-b40b-4c5c-b019-a749eec52d88 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 00628e5e-4c5b-2573-e063-6294a90a0e3b | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca36f94c-2215-436f-ada8-7319f4f3e054 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | b25c01e0-273a-4f8f-a37e-9b17e5cf378f | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8034 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8035 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6452 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6452 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6452 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6452 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6453 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6454 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 50090-3317 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Unit Dose Services | ANDA | Current |
| 55154-7878 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7878 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7878 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7878 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7889 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7889 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7889 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-160 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-160 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-165 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-435 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-435 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Lake Erie Medical DBA Qua | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2995 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2996 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-2997 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Apotex Corp. | ANDA | Current |
| 63187-172 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-172 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-181 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-181 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-716 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-716 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 68788-9370 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9370 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9371 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9371 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0686 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0716 | Duloxetine Hydrochloride | Duloxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |