Application 090774
- Type
- ANDA
- Sponsor
- TORRENT
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 |
|---|---|---|---|---|---|---|---|
| A090774-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | ||
| A090774-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | ||
| A090774-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2013-12-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090774-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2013-12-11 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090774-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090774-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090774-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090774-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090774-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090774-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090774-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090774-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090774-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090774-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090774-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090774-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090774-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090774-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090774-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090774-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090774-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090774-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090774-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090774-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090774-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090774-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090774-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090774-001 | AB | 1 | 4b0b4de00fa7… |
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 | NuCare Pharmaceuticals,Inc. | df61b895-c358-827b-e053-2995a90a9b60 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 3adfceb3-5f89-4bcf-b874-e3cb572a98b6 | 2024-11-07 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 41876761-9d5b-4190-a200-6a822c54582e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 0c82422a-d493-4dda-8626-0d9baa25db8c | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | ca376622-d32c-4e6e-8af4-8e24a8d20d83 | 2024-08-06 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | A-S Medication Solutions | be33f3cb-6fd1-4377-816e-84bd49370e9e | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 675f999d-46b2-45da-b17e-58cc2ba180b1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b1f1345c-3b7f-4228-b7b7-b9a4648050e5 | 2024-03-28 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | BluePoint Laboratories | a95cc04c-58e9-487f-8992-ef30df03a3cd | 2024-02-14 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 41c86c02-68c0-4db5-af1a-941b0d2ffe11 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | MARKSANS PHARMA LIMITED | 3686cde5-f76d-4d16-aa5d-caceb8408f8c | 2023-10-05 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | f5e7503a-b28f-4cd0-a4ee-47bdca88d54b | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | dcfd62c7-1687-4e9b-9ae4-5a44929ac765 | 2023-09-15 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 22a8cc15-17fb-4c4e-8d2a-de5755ed6031 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 51c342c9-b9c6-467d-8fea-b73d72e3febc | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | c34f6115-f447-450f-8c83-58f3c51a76c9 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b102b8e6-d58f-419c-bb35-720bafa13294 | 2020-03-17 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| DULOXETINE DELAYED-RELEASE | DULOXETINE HYDROCHLORIDE | Proficient Rx LP | 407b62b9-5b32-4bac-a2b0-7df499279248 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
| Duloxetine Delayed-Release | DULOXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | db686a0a-9b2a-4017-8bd1-b981da47c2f3 | 2019-01-11 | Boxed warning, Warnings, Adverse reactions | DULOXETINE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0615-7894 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7895 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8203 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8203 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8203 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8203 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8204 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8204 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8204 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8204 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8290 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8290 | Duloxetine hydrochloride | Duloxetin hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-109 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-110 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-111 | Duloxetine hydrochloride | Duloxetin hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 63187-457 | Duloxetine hydrochloride | Duloxetin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-457 | Duloxetine hydrochloride | Duloxetin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-457 | Duloxetine hydrochloride | Duloxetin hydrochloride | Proficient Rx LP | ANDA | Current |
| 64725-1100 | Duloxetine hydrochloride | Duloxetin hydrochloride | TYA Pharmaceuticals | ANDA | Current |
| 70518-0363 | Duloxetine hydrochloride | Duloxetin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1272 | Duloxetine hydrochloride | Duloxetin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1272 | Duloxetine hydrochloride | Duloxetin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1273 | Duloxetine hydrochloride | Duloxetin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1273 | Duloxetine hydrochloride | Duloxetin hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9292 | ORIG | 2013-12-13 |