Application 209484
- Type
- ANDA
- Sponsor
- HI TECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | GEL;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209484-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 |
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 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | AB | 2018-11-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209484-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2018-11-21 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | A209484-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209484-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209484-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209484-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209484-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209484-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209484-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209484-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209484-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209484-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209484-001 | 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 | DICLOFENAC SODIUM | Redpharm Drug | 37362eb4-db16-f4ad-e063-6394a90a42aa | 2025-12-13 | Warnings | Diclofenac Sodium DICLOFENAC SODIUM |
| UP AND UP ARTHRITIS PAIN RELIEVER | DICLOFENAC SODIUM | Target Corporation | 3a9b32af-a3cd-496b-9698-0421443e0385 | 2025-12-08 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM 1% | SOLA Pharmaceuticals | bdbe3f24-3015-1f32-e053-2995a90aa665 | 2025-12-08 | Warnings | Diclofenac Sodium |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 4539e9e7-5d82-3b36-e063-6394a90a1396 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Aleve Arthritis Pain Gel | DICLOFENAC SODIUM | Bayer HealthCare LLC | bad675d1-1204-0136-e053-2995a90a994e | 2025-12-04 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL | Proficient Rx LP | 140a2c64-4996-4da3-b10f-1b8235ebde9d | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL | Alembic Pharmaceuticals Inc. | 30c3c3c5-b4f3-4321-ae25-b2c588ad0551 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium |
| Diclofenac Sodium | DICLOFENAC SODIUM | Aurobindo Pharma Limited | e5c0863a-edb7-4f46-a396-c9b2d8785cf8 | 2025-11-19 | Warnings | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | SOLA Pharmaceuticals, LLC | b8072af2-9940-4827-9fbd-de46ad8bf929 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| ARTHRITIS PAIN RELIEVER | DICLOFENAC SODIUM | H E B | 027803c5-85ae-4b86-8bd4-e61f8f34d036 | 2025-11-17 | Warnings | DICLOFENAC SODIUM |
| ARTHRITIS PAIN RELIEVING | DICLOFENAC SODIUM | Meijer, Inc. | 5cc570c6-2585-4d1a-9352-b1161458af9a | 2025-11-17 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | PHOENIX RX LLC | 41472cca-278b-934b-e063-6294a90aaf5d | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | PHOENIX RX LLC | 4382cc15-8978-4f3b-e063-6394a90a9ecb | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium Topical 1% | DICLOFENAC SODIUM | YYBA CORP | 043df5d2-6f3e-311f-e063-6294a90a23d7 | 2025-11-10 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 0b4fd47f-903c-097b-e063-6394a90a49ab | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Lupin Pharmaceuticals, Inc. | 609c5344-9c97-4fa8-ad53-d0f622ce64ec | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | Dr. Reddy's Laboratories Inc. | c88b2512-0255-658d-252a-c006275159b0 | 2025-10-28 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | Chain Drug Marketing Association INC | 625d21e8-0731-1157-30fe-9f9868ff8dc4 | 2025-10-28 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | GERI-CARE PHARMACEUTICALS CORP | 91fc618a-edd0-5944-083f-c00075476f55 | 2025-10-28 | Warnings | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | GLENMARK PHARMACEUTICALS INC., USA | dab3ae60-0135-43b3-a1d0-8752720af82a | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM 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 |
|---|---|---|---|---|---|
| 50383-272 | Diclofenac Sodium | Diclofenac Sodium | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-272 | Diclofenac Sodium | Diclofenac Sodium | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-272 | Diclofenac Sodium | Diclofenac Sodium | Hi-Tech Pharmacal Co., Inc. | ANDA | Current |
| 50383-528 | Diclofenac Sodium | Diclofenac Sodium | Akorn | ANDA | Current |
| 70518-2673 | Diclofenac Sodium | Diclofenac Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2673 | Diclofenac Sodium | Diclofenac Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2673 | Diclofenac Sodium | Diclofenac Sodium | REMEDYREPACK INC. | ANDA | Current |