Application 021005
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SOLARAZE | DICLOFENAC SODIUM | GEL;TOPICAL | 3% | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021005-001 | SOLARAZE | DICLOFENAC SODIUM | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 |
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| 2026-08 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | RLD | 2000-10-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021005-001 | SOLARAZE | 3% | GEL / TOPICAL | AB | RLD, RS | 2000-10-16 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021005-001 | SOLARAZE | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL / TOPICAL | RLD | 2000-10-16 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021005-001 | AB | 1 | 74a2ff9319b5… |
| 2021-03-12 10:30 UTC | 2021-03 | N021005-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021005-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021005-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021005-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021005-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021005-001 | AB | 1 | ea99ee380514… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0168-0803 | DICLOFENAC SODIUM | diclofenac sodium | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0168-0844 | DICLOFENAC SODIUM | diclofenac sodium | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 10337-803 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-844 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-844 | Solaraze | diclofenac sodium | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80373 | SUPPL | 2024-11-25 |
| 80302 | SUPPL | 2024-11-22 |
| 72637 | SUPPL | 2022-11-17 |
| 72636 | SUPPL | 2022-11-17 |
| 72618 | SUPPL | 2022-11-15 |
| 70713 | SUPPL | 2022-04-06 |
| 70712 | SUPPL | 2022-04-06 |
| 70706 | SUPPL | 2022-04-06 |
| 67381 | SUPPL | 2021-05-03 |
| 67266 | SUPPL | 2021-04-30 |
| 23215 | SUPPL | 2016-05-18 |
| 14147 | SUPPL | 2016-05-11 |
| 4018 | SUPPL | 2016-05-11 |
| 26461 | SUPPL | 2011-12-14 |
| 14146 | SUPPL | 2011-12-14 |
| 26460 | SUPPL | 2007-06-07 |
| 4017 | SUPPL | 2004-07-28 |
| 26459 | SUPPL | 2004-03-24 |
| 21349 | ORIG | 2003-07-08 |
| 35862 | SUPPL | 2003-05-29 |
| 26458 | SUPPL | 2003-05-29 |
| 14145 | ORIG | 2000-10-16 |
| 4016 | ORIG | 2000-10-16 |