Application 090739
- Type
- ANDA
- Sponsor
- ZYDUS HLTHCARE
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 |
|---|---|---|---|---|---|---|---|
| A090739-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | |
| A090739-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | |
| A090739-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | |
| A090739-004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090739-001 | AB |
| A090739-002 | AB |
| A090739-003 | AB |
| A090739-004 | 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 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-01-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2023-04-18 | 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 | A090739-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090739-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090739-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090739-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090739-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090739-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090739-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090739-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090739-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090739-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090739-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090739-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090739-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090739-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090739-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090739-004 | AB | 1 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Duloxetine | DULOXETINE | Zydus Lifesciences Limited | f36b414e-ace4-4f04-a80f-75bb25db430d | 2024-11-28 | 090739 ANDA090739 65841-800 65841-801 65841-799 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4011 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50090-4403 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50436-0387 | Duloxetine | Duloxetine | Unit Dose Services | ANDA | Current |
| 65841-799 | Duloxetine | Duloxetine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-799 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-799 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-799 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-800 | Duloxetine | Duloxetine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-800 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-800 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-800 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-801 | Duloxetine | Duloxetine | Zydus Lifesciences Limited | ANDA | Current |
| 65841-801 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-801 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 65841-801 | Duloxetine | Duloxetine | Cadila Healthcare Limited | ANDA | Current |
| 68001-255 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68001-255 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68001-256 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68001-256 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68001-257 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68001-257 | Duloxetine | Duloxetine | BluePoint Laboratories | ANDA | Current |
| 68382-385 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-385 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-385 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-385 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-386 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-386 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-386 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-386 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-387 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-387 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-387 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-387 | Duloxetine | Duloxetine | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-1066 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1066 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9289 | ORIG | 2014-01-10 |