Application 215787
- Type
- ANDA
- Sponsor
- SENORES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG | No | No |
| 002 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215787-001 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | |
| A215787-002 | DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215787-001 | AB |
| A215787-002 | 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 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A215787-002 | DICLOFENAC POTASSIUM | 25MG | TABLET / ORAL | AB | 2023-11-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215787-001 | DICLOFENAC POTASSIUM | 50MG | TABLET / ORAL | AB | 2023-03-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215787-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215787-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215787-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215787-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215787-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215787-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215787-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215787-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215787-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215787-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215787-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215787-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215787-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215787-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215787-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215787-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215787-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215787-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215787-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215787-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215787-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215787-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215787-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215787-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215787-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215787-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215787-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A215787-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215787-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215787-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215787-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215787-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215787-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215787-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215787-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215787-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215787-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215787-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A215787-001 | AB | 1 | 053a50430f4f… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215787-001 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Amerisyn LLC | b0931350-28a9-4f00-9254-1d72e31f04c3 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | VICI Pharmaceuticals, Inc | 544a869e-60ef-627b-e063-6294a90a3fd8 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | PHOENIX RX LLC | 43448b74-6c02-a581-e063-6394a90a63ba | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | SOLA Pharmaceuticals, LLC | e770efc8-bbad-4103-98e4-e31019a540f5 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | INA Pharmaceutics Inc, | 6c703075-b9a3-42de-87f6-fd1e1ef4b2e3 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | SOLA Pharmaceuticals, LLC | 26bf3a4a-42c6-cb59-e063-6394a90abd8b | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Doc Rx | 6394ab5f-b3ff-4397-97eb-ff92485c5ec0 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Phoenix RX LLC | 3fd418ac-49f6-d520-e063-6394a90afbd8 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Golden State Medical Supply, Inc. | 26d0ed73-b7a6-cbd8-e063-6394a90a9a31 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Happy Robin, LLC | 3f91023f-9db9-88ba-e063-6394a90abd44 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Amici Pharma, Inc | c4ce1497-9cb1-4632-b1a2-4f61043c018d | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Advanced Rx of Tennessee, LLC | 295d167c-eb56-8e14-e063-6394a90ad325 | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Advanced Rx of Tennessee, LLC | 295d5dab-8890-d76e-e063-6394a90ad402 | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Cintex Services, LLC | 0cdea9d3-fada-b00e-e063-6394a90ad5d9 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Havix Group Inc d-b-a Aavis Pharmaceuticals | 30ab7b30-cc90-4b84-8caf-21058f1d37fa | 2023-06-27 | Boxed warning, Warnings, Adverse reactions | 215787 ANDA215787 |