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| DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CATAFLAM | DICLOFENAC POTASSIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | |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| CATAFLAM | DICLOFENAC POTASSIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 |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| 2026-08 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |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| 2026-08 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |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| 2026-07 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | caaa826d4ba7… | |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 | Advanced Rx of Tennessee, LLC | 295d5dab-8890-d76e-e063-6394a90ad402 | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Cambia | DICLOFENAC POTASSIUM | Assertio Therapeutics, Inc. | d249ced1-4ca0-4f57-adcb-23440f58f659 | 2024-12-11 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Aurobindo Pharma Limited | 7efdbe23-503a-4f38-a0b6-c003033f0de7 | 2024-12-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | NuCare Pharmaceuticals, Inc. | 26a8f723-2a8e-8a5a-e063-6394a90a7bae | 2024-11-11 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | NuCare Pharmaceuticals, Inc. | 3da9e463-1b2f-54c0-e054-00144ff88e88 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| LOFENA | DICLOFENAC POTASSIUM | Carwin Pharmaceutical Associates, LLC | 49bd64cc-5edb-44f2-8e24-1249f6a76663 | 2024-01-08 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Leading Pharma, LLC | 9dd418b2-4b0e-498c-b453-f580c69ddc6d | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | A-S Medication Solutions | 112e7c94-23c8-451e-ae71-eb89a6eb2cb2 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Carwin Pharmaceutical Associates, LLC | bce95bb3-3097-4e7d-8d29-0870bb729212 | 2023-11-08 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | 717341fc-e067-0005-215c-053f6d12e0d1 | 2023-10-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Proficient Rx LP | 94586867-c75b-4d60-be1d-03a9e4b7cd10 | 2023-09-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Ascend Laboratories, LLC | f675a627-c944-4ec6-8c08-b5fdb78dc269 | 2022-10-21 | 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 |