Application 208706
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A208706-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | |
| A208706-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | |
| A208706-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 |
| A208706-004 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208706-001 | AB |
| A208706-002 | AB |
| A208706-003 | AB |
| A208706-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2017-01-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2017-01-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-004 | DULOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-03-11 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208706-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208706-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208706-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208706-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208706-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208706-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208706-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208706-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208706-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208706-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208706-004 | AB | 1 | d06236e962d9… |
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 | REMEDYREPACK INC. | ed164dbb-e713-42d1-a78e-31145578b9f8 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | St. Mary's Medical Park Pharmacy | 9221f3e5-17b8-ea74-e053-2a95a90ad1a8 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 60760-462 |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | ac903bda-76af-4aba-9c8a-ebf7066e05ee | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | St. Mary's Medical Park Pharmacy | 9221aea1-8de1-b94e-e053-2a95a90a1eae | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 60760-461 |
| Duloxetine | DULOXETINE | HAWAII REPACK, INC. | 79bfd6be-a1ff-4786-b4e2-abbd0a3e3932 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | b149641a-03e6-4fee-91f3-7ba8e01196bd | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 70518-1054 |
| Duloxetine | DULOXETINE | St. Mary's Medical Park Pharmacy | 39fa4247-e864-f653-e063-6394a90ac98d | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | 22a2ad76-0841-46fe-85e1-101afd924939 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Preferred Pharmaceuticals Inc. | e86eb765-ac9c-4ed9-bce8-819151559394 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 68788-7935 |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals, Inc. | 4e42a04a-ab8e-3ec9-e063-6394a90a4565 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | NuCare Pharmaceuticals,Inc. | 075fc7c9-7b4b-b9c3-e063-6394a90a926e | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine D/R | DULOXETINE D/R | Direct_Rx | 4a66fde2-4cce-b92e-e063-6294a90a63ee | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Bryant Ranch Prepack | 5fa0eda4-0886-415c-a30c-ae9729f16974 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | 9286ec0b-45ae-4a09-a0ad-556ec92aab63 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 70518-1139 |
| Duloxetine | DULOXETINE | REMEDYREPACK INC. | ba4adb77-45be-4310-a877-766692f22e5e | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 70518-1011 |
| Duloxetine | DULOXETINE | PD-Rx Pharmaceuticals, Inc. | db85a82d-84f1-41c8-964b-ac94ae4d8e7b | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Northwind Health Company, LLC | c194a7b0-1e7e-a32b-e053-2995a90a7dbd | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 51655-237 |
| Duloxetine | DULOXETINE | A-S Medication Solutions | fa5657a8-c6d9-474a-9d1a-b75b41b4327f | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | A-S Medication Solutions | 7685a825-3c06-433d-ba98-4019c6ed2583 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
| Duloxetine | DULOXETINE | Aphena Pharma Solutions - Tennessee, LLC | c482d64a-73dd-4af2-9b3c-efff47e7395c | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 208706 ANDA208706 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-097 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-098 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-099 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-164 | Duloxetine | Duloxetine | Ajanta Pharma Limited | ANDA | Current |
| 50090-5940 | Duloxetine | Duloxetine | A-S Medication Solutions | ANDA | Current |
| 50436-0198 | Duloxetine | Duloxetine | Unit Dose Services | ANDA | Current |
| 50436-0199 | Duloxetine | Duloxetine | Unit Dose Services | ANDA | Current |
| 51655-237 | Duloxetine | Duloxetine | Northwind Pharmaceuticals | ANDA | Current |
| 53002-1494 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1494 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1561 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1561 | Duloxetine | Duloxetine | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Qua | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-605 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Quality Care Products LLC | ANDA | Current |
| 55700-628 | Duloxetine | Duloxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 55700-727 | Duloxetine | Duloxetine | Quality Care Products, LLC | ANDA | Current |
| 60760-461 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-461 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-462 | Duloxetine | Duloxetine | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-8051 | Duloxetine | Duloxetine | Bryant Ranch Prepack | ANDA | Current |
| 63629-8051 | Duloxetine | Duloxetine | Bryant Ranch Prepack | ANDA | Current |
| 68071-4700 | Duloxetine | Duloxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4700 | Duloxetine | Duloxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7672 | Duloxetine | Duloxetine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7935 | Duloxetine | Duloxetine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7935 | Duloxetine | Duloxetine | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1011 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1054 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1139 | Duloxetine | Duloxetine | REMEDYREPACK INC. | ANDA | Current |