Application 204592
- Type
- NDA
- Sponsor
- ZYLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZORVOLEX | DICLOFENAC | CAPSULE;ORAL | 18MG | Yes | No |
| 002 | ZORVOLEX | DICLOFENAC | CAPSULE;ORAL | 35MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204592-001 | ZORVOLEX | DICLOFENAC | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | |
| N204592-002 | ZORVOLEX | DICLOFENAC | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204592-001 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | |
| N204592-001 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | |
| N204592-001 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | |
| N204592-001 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | |
| N204592-001 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | |
| N204592-001 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | |
| N204592-001 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | |
| N204592-002 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | |
| N204592-002 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | |
| N204592-002 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | |
| N204592-002 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | |
| N204592-002 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | |
| N204592-002 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | |
| N204592-002 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204592-002 | ZORVOLEX | 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204592-001 | ZORVOLEX | 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD | 2013-10-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204592-001 | ZORVOLEX | 18MG | CAPSULE / ORAL | RLD | 2013-10-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD, RS | 2013-10-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204592-001 | ZORVOLEX | 18MG | CAPSULE / ORAL | RLD | 2013-10-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD, RS | 2013-10-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204592-001 | ZORVOLEX | 18MG | CAPSULE / ORAL | RLD | 2013-10-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD, RS | 2013-10-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204592-001 | ZORVOLEX | 18MG | CAPSULE / ORAL | RLD | 2013-10-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD, RS | 2013-10-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204592-001 | ZORVOLEX | 18MG | CAPSULE / ORAL | RLD | 2013-10-18 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204592-002 | ZORVOLEX | 35MG | CAPSULE / ORAL | RLD, RS | 2013-10-18 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-001 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204592-002 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-001 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204592-002 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 9180096 | 2030-04-23 | Drug product | 2015-11-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-001 | 9186328 | 2030-04-23 | U-55 | 2015-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | 8679544 | 2030-04-23 | Drug product | 2014-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | 8999387 | 2030-04-23 | U-55 | 2015-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | 9017721 | 2030-04-23 | Drug product | 2015-04-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | 9173854 | 2030-04-23 | Drug product | 2015-11-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204592-002 | 9180095 | 2030-04-23 | U-55 | 2015-11-12 | 31067a03dcf5… |
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 Sodium | DICLOFENAC | Preferred Pharmaceuticals Inc. | 937e9ba5-cdad-4e72-a77a-bad699e1b236 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Xiclo | DICLOFENAC | Strand Health Group | 2d93a01c-40a9-8fb0-e063-6394a90a2cc6 | 2025-12-18 | Warnings | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | PHOENIX RX LLC | 41dab520-5651-a4c5-e063-6394a90a2962 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| DICLOFENAC SODIUM | DICLOFENAC | Encube Ethicals, Inc. | e7304b3e-530a-4519-aed0-bed4512d8925 | 2025-07-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Xiclo | DICLOFENAC | Asclemed USA, Inc. | 71cd0d4e-671c-4372-9b1f-7b34cf887824 | 2025-06-07 | Warnings | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Amneal Pharmaceuticals LLC | 45321aec-368d-4ca4-a0c5-2ce56fae74b2 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac DR | DICLOFENAC | Advanced Rx of Tennessee, LLC | af8a30fb-ead8-7e29-e053-2a95a90a040f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Advanced Rx Pharmacy of Tennessee, LLC | fc100cb2-16d9-f67d-e053-6294a90a0f2e | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac sodium | DICLOFENAC | Scholl's Wellness Company | 8dcbce69-945b-4913-a279-ee10871f6580 | 2024-11-14 | Warnings | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Amneal Pharmaceuticals LLC | 78873f83-cea9-44d4-8ad4-8cb9257e5c7f | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac sodium | DICLOFENAC | Amneal Pharmaceuticals NY LLC | 1084e0c3-6d75-4090-84dc-02a18e0299b9 | 2023-12-29 | Warnings | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Proficient Rx LP | f4da38af-c5bd-4d4a-a6f3-c2933f223809 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Bryant Ranch Prepack | e5f8284a-1aa9-4a36-a6ad-fa153c613f34 | 2023-05-26 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | A-S Medication Solutions | 58178f0d-3960-48e3-91ba-150f691be241 | 2023-05-09 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
| Diclofenac Sodium | DICLOFENAC | Asclemed USA, Inc. | 9df599de-6412-a94e-e053-2995a90a1741 | 2022-10-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42211-203 | Zorvolex | diclofenac | Iroko Pharmaceuticals LLC | NDA | Current |
| 42211-203 | Zorvolex | diclofenac | Iroko Pharmaceuticals LLC | NDA | Current |
| 42211-204 | Zorvolex | diclofenac | Iroko Pharmaceuticals LLC | NDA | Current |
| 42211-204 | Zorvolex | diclofenac | Iroko Pharmaceuticals LLC | NDA | Current |
| 69344-203 | Zorvolex | diclofenac | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-203 | Zorvolex | diclofenac | Egalet US Inc. | NDA | Current |
| 69344-203 | Zorvolex | diclofenac | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-204 | Zorvolex | diclofenac | Zyla Life Sciences US Inc. | NDA | Current |
| 69344-204 | Zorvolex | diclofenac | Egalet US Inc. | NDA | Current |
| 69344-204 | Zorvolex | diclofenac | Zyla Life Sciences US Inc. | NDA | Current |
| 73480-242 | DICLOFENAC | Diclofenac | TriVue Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80394 | SUPPL | 2024-11-25 |
| 80393 | SUPPL | 2024-11-25 |
| 80313 | SUPPL | 2024-11-22 |
| 67360 | SUPPL | 2021-05-03 |
| 67359 | SUPPL | 2021-05-03 |
| 67285 | SUPPL | 2021-04-30 |
| 52767 | SUPPL | 2018-02-28 |
| 52766 | SUPPL | 2018-02-28 |
| 40397 | SUPPL | 2016-05-11 |
| 19575 | SUPPL | 2016-05-11 |
| 10362 | SUPPL | 2016-05-10 |
| 10361 | SUPPL | 2016-05-10 |
| 32570 | SUPPL | 2014-08-27 |
| 10360 | SUPPL | 2014-08-27 |
| 19574 | SUPPL | 2014-08-26 |
| 19573 | SUPPL | 2014-08-26 |
| 24472 | ORIG | 2014-03-26 |
| 22959 | ORIG | 2014-03-26 |
| 23515 | ORIG | 2013-10-24 |
| 19572 | ORIG | 2013-10-22 |
| 10359 | ORIG | 2013-10-22 |