Application 020142
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CATAFLAM | DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CATAFLAM | DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020142-001 | CATAFLAM | DICLOFENAC POTASSIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | |
| N020142-002 | CATAFLAM | DICLOFENAC POTASSIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 |
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| 2026-08 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020142-002 | CATAFLAM | 50MG | TABLET / ORAL | RLD | 1993-11-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020142-002 | CATAFLAM | 50MG | TABLET / ORAL | RLD | 1993-11-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1993-11-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | 1993-11-24 | 74a2ff9319b5… |
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 | Trifluent Pharma LLC | 8fdb1036-c0d8-4288-ac37-6512b05672ef | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | INA Pharmaceutics Inc | 5ecd99fe-cb74-4a65-9636-2aefd2416ece | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac potassium | DICLOFENAC POTASSIUM | TEVA PHARMACEUTICALS, INC. | d9685883-9d0b-81da-e053-2a95a90ab8d8 | 2025-10-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| ZIPSOR | DICLOFENAC POTASSIUM | Assertio Therapeutics, Inc. | c982eca0-fc41-11e1-a9c8-0002a5d5c51b | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Golden State Medical Supply, Inc. | c2c79af6-f35e-5cdf-e053-2a95a90a4d63 | 2025-06-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Amici Pharma Inc. | f2908870-a517-491f-8771-4100d11b4b64 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Lifsa Drugs LLC | 90a0539a-7227-4b91-8b22-25b6f23ef35f | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Preferred Pharmaceuticals Inc. | 8dfaa874-d6cf-4107-b57f-25dab02aa201 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Preferred Pharmaceuticals Inc. | 4f482f98-ef10-45d7-8e9f-9cf291d93092 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Leading Pharma, LLC | 698690a7-4978-4457-b123-0a670bbab481 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| diclofenac potassium | DICLOFENAC POTASSIUM | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | d64537c8-e397-4d17-b95c-3092668260aa | 2025-03-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | PD-Rx Pharmaceuticals, Inc. | 08e41a9d-644c-4ac6-aba3-38d7c3f36d36 | 2025-03-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Marlex Pharmaceuticals, Inc. | 30c7197b-7110-d8a7-e063-6394a90addfb | 2025-03-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Coupler LLC | 2eead069-f954-abb2-e063-6394a90a14ff | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac potassium | DICLOFENAC POTASSIUM | Camber Pharmaceuticals, Inc. | 9261a9d6-f772-41a2-ac99-8608c04c355b | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | 69ab6f91-5770-480c-8bd1-8c1f1f8bfdb5 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | 8c54e404-2dbd-49cd-8235-b2a708bae563 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Teva Pharmaceuticals USA, Inc. | 77b60a0c-e49a-4ad4-abb1-b662c24ab782 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Archis Pharma LLC | 0d83cab3-c698-4763-9e77-27d72ba94e30 | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Advanced Rx of Tennessee, LLC | 295d167c-eb56-8e14-e063-6394a90ad325 | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67341 | SUPPL | 2021-05-03 |
| 67340 | SUPPL | 2021-05-03 |
| 67252 | SUPPL | 2021-04-29 |
| 2063 | SUPPL | 2016-05-12 |
| 34296 | SUPPL | 2016-05-11 |
| 12249 | SUPPL | 2011-03-04 |
| 12248 | SUPPL | 2011-03-04 |
| 21204 | SUPPL | 2011-02-28 |
| 21203 | SUPPL | 2011-02-28 |
| 23148 | ORIG | 2009-11-16 |
| 34295 | SUPPL | 2009-03-17 |
| 2062 | SUPPL | 2009-03-03 |
| 21202 | SUPPL | 2006-01-30 |
| 34294 | SUPPL | 2006-01-25 |