Application 020947
- Type
- NDA
- Sponsor
- NUVO PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENNSAID | DICLOFENAC SODIUM | SOLUTION;TOPICAL | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020947-001 | PENNSAID | DICLOFENAC SODIUM | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | |
| N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | |
| N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | |
| N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | |
| N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 |
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| 2026-08 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020947-001 | PENNSAID | 1.5% | SOLUTION / TOPICAL | RLD | 2009-11-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020947-001 | PENNSAID | 1.5% | SOLUTION / TOPICAL | RLD | 2009-11-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020947-001 | PENNSAID | 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / TOPICAL | RLD | 2009-11-04 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | 8217078 | 2029-07-10 | U-1248 | 2012-07-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | 8618164 | 2029-07-10 | U-1477 | 2014-01-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | 8741956 | 2029-07-10 | U-1435 | 2014-06-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | 8546450 | 2030-08-09 | U-1435 | 2013-10-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020947-001 | 8546450 | 2030-08-09 | U-1436 | 2013-10-04 | 03ed91905a0d… |
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 Delayed Release | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | c933eaad-ba53-4130-90db-a66f89dfc29f | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Oceanside Pharmaceuticals | c48113e0-9f1e-4086-b18f-3204c0d2a689 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Cipla USA Inc. | daf52f5a-1bb7-4808-ab98-483ab9e8cfa0 | 2025-03-11 | Warnings | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Alembic Pharmaceuticals Limited | 048ede6a-b7cd-4100-8979-519bd44906c8 | 2025-03-11 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 31b56330-6870-48b7-a8c4-0639e0766b25 | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Voltaren Arthritis Pain | DICLOFENAC SODIUM | Haleon US Holdings LLC | 30a94282-0892-442a-aa10-6525cbd4fe88 | 2025-02-11 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | af480e78-ff65-4709-af26-c430aefb77d6 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 5508f80d-5f11-4959-8e42-9055f0169cfc | 2025-02-08 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 0d1d19e5-4ffe-af95-e063-6394a90a7abf | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | d70fcd8e-a72b-41ef-ac26-e0f2f279f062 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Actavis Pharma, Inc. | 74169b2d-ac56-4757-86c4-cdcfcd5f4eb5 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Coupler LLC | 2ce0741a-7bc7-8aec-e063-6294a90ae9ef | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | 49013aad-475c-4efb-84c6-15a5d4664fbf | 2025-01-29 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Aspercreme Arthritis | DICLOFENAC SODIUM | Chattem, Inc. | 762b7ef4-166c-43b8-9acd-2b9e7fa0bf36 | 2025-01-28 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Direct_Rx | f80b0b95-f4da-2d6c-e053-6294a90acf92 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Direct_Rx | 0c41977f-8dad-1d26-e063-6294a90a9b22 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | DIRECT RX | a5b33bf7-8113-9c54-e053-2995a90a79d8 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Alembic Pharmaceuticals Inc. | 02e90e33-384f-4e29-b508-2503def22214 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 62edf474-9c16-d535-e053-2991aa0a4a09 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | 81bfeada-6589-4528-bea5-059ab0fabb43 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 26282 | SUPPL | 2016-05-11 |
| 13807 | SUPPL | 2016-05-11 |
| 13806 | SUPPL | 2016-05-11 |
| 3835 | SUPPL | 2016-05-11 |
| 26281 | SUPPL | 2013-10-24 |
| 35704 | SUPPL | 2013-10-21 |
| 26280 | SUPPL | 2011-07-18 |
| 24184 | ORIG | 2010-05-06 |
| 21297 | ORIG | 2010-05-06 |
| 35703 | SUPPL | 2010-04-04 |
| 13805 | SUPPL | 2010-04-04 |
| 26279 | SUPPL | 2010-03-31 |
| 3834 | SUPPL | 2010-03-31 |
| 43687 | ORIG | 2009-11-18 |
| 26278 | ORIG | 2009-11-13 |
| 13804 | ORIG | 2009-11-12 |