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| DICLOFENAC POTASSIUM | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DICLOFENAC POTASSIUM | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CATAFLAM | DICLOFENAC POTASSIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | |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| CATAFLAM | DICLOFENAC POTASSIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 |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| 2026-08 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |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| 2026-08 | N020142-002 | CATAFLAM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | 84e616aacf4f… | |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| 2026-07 | N020142-001 | CATAFLAM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-11-24 | caaa826d4ba7… | |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 | Par Health USA, LLC | 2d45648f-cbea-41a4-8e3e-007b7bb7912c | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Sun Pharmaceutical Industries, Inc. | 68a926a2-b818-420f-9c9a-fd91dc5a8f36 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| diclofenac potassium | DICLOFENAC POTASSIUM | Strides Pharma Science Limited | 2184805c-b9b3-4be8-8726-4ce1b1197477 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | REMEDYREPACK INC. | c4976d69-ca06-4263-9240-6fd8b44a9b6d | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | NuCare Pharmaceuticals,Inc. | d61cbb27-737d-948c-e053-2a95a90adaca | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | 86461915-9bc1-43d4-8d92-6eef3e56bd90 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Bryant Ranch Prepack | e29e7aea-0bcd-46e5-b011-fbaf5aa2244a | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Torrent Pharmaceuticals Limited | 6a945fa8-6c62-40ba-ae97-b994cc90583e | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| ZIPSOR | DICLOFENAC POTASSIUM | Assertio Specialty Pharmaceuticals LLC | ed2a8868-78eb-47b8-8f46-0f70e2891e07 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Umedica Laboratories USA Inc. | 33930285-dd97-415c-9e2a-491bd7b12af9 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | AvKARE | 21dc9953-4e6d-50f0-e063-6294a90ac4ef | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | PHOENIX RX LLC | 43448b74-6c02-a581-e063-6394a90a63ba | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | SOLA Pharmaceuticals, LLC | e770efc8-bbad-4103-98e4-e31019a540f5 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Northwind Health Company, LLC | f2b6a4dd-e4e2-4acc-e053-2995a90aebf2 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | Nivagen Pharmaceuticals, Inc. | eb52a015-23cd-40f6-bf83-6749fc34947c | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Chartwell RX, LLC | 3a837a3e-10b2-4256-b515-80c863318ccb | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | SOLA Pharmaceuticals, LLC | 26bf3a4a-42c6-cb59-e063-6394a90abd8b | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Doc Rx | 6394ab5f-b3ff-4397-97eb-ff92485c5ec0 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Phoenix RX LLC | 3fd418ac-49f6-d520-e063-6394a90afbd8 | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC POTASSIUM |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Ingenus Pharmaceuticals, LLC | 6926444f-0dca-4aeb-812e-755a83b149f4 | 2025-10-21 | 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 |