Application 210986
- Type
- ANDA
- Sponsor
- ENCUBE
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 |
|---|---|---|---|---|---|---|---|
| A210986-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 |
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 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210986-001 | DICLOFENAC SODIUM | 1% | GEL / TOPICAL | 2020-01-27 | a50c72e98297… |
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 TOPICAL GEL, 1%, | A-S Medication Solutions | 4500bf3c-394b-4397-8751-8dac2097fc41 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 210986 ANDA210986 |
| Gencare-Arthritis Pain Relief | DICLOFENAC SODIUM | Pioneer Life Sciences, LLC | 4b1438bb-8591-4237-abcb-91491f34ad8f | 2024-09-10 | Warnings | 210986 ANDA210986 |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | NuCare Pharmaceuticals,Inc. | 0326ea5b-3e1a-dee2-e063-6294a90a13b8 | 2024-07-09 | Warnings | 210986 ANDA210986 |
| Curist Arthritis Relief | DICLOFENAC SODIUM | Little Pharma, Inc. | e638a98e-e6d7-36ed-e053-2995a90af2ca | 2024-06-21 | Warnings | 210986 ANDA210986 72559-020 |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | Simple Diagnostics | 13925cd5-e121-80d2-e063-6394a90af9a9 | 2024-03-19 | Warnings | 210986 ANDA210986 |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL GEL, 1%, | A-S Medication Solutions | 828b5de2-77a7-4893-ab47-dffc8ea73693 | 2023-12-28 | Boxed warning, Warnings, Adverse reactions | 210986 ANDA210986 |
| Crcle Diclofenac Sodium Topical Gel 1% | DICLOFENAC SODIUM TOPICAL GEL 1% | Innovus Pharmaceuticals Inc. | b373c202-5795-418f-989c-1ec5837145af | 2023-03-24 | Warnings | 210986 ANDA210986 |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM TOPICAL GEL, 1% | Proficient Rx LP | b4694451-a13d-484e-92c4-c03a6fcbb511 | 2023-01-01 | Warnings | 210986 ANDA210986 |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL GEL, 1%, | Proficient Rx LP | 7e98952e-9b95-4296-9c23-c0ff4b82b2b7 | 2021-04-01 | Boxed warning, Warnings, Adverse reactions | 210986 ANDA210986 71205-552 |
| Diclofenac Sodium | DICLOFENAC SODIUM TOPICAL GEL, 1%, | Asclemed USA, Inc. | 988abe66-0b3b-4c13-87b4-adc913227fc5 | 2020-10-24 | Boxed warning, Warnings, Adverse reactions | 210986 ANDA210986 76420-091 |
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 |
|---|---|---|---|---|---|
| 0363-7065 | Diclofenac Sodium Topical Gel 1% | diclofenac sodium topical gel, 1% | Walgreens Company | ANDA | Current |
| 0363-7065 | Diclofenac Sodium Topical Gel 1% | diclofenac sodium topical gel, 1% | Walgreens Company | ANDA | Current |
| 0363-7065 | Diclofenac Sodium Topical Gel 1% | diclofenac sodium topical gel, 1% | Walgreens Company | ANDA | Current |
| 21922-009 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Encube Ethicals Private Limited | ANDA | Current |
| 21922-009 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Encube Ethicals Private Limited | ANDA | Current |
| 21922-044 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-044 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-044 | Diclofenac Sodium | diclofenac sodium topical gel, 1% | Encube Ethicals Private Limited | ANDA | Current |
| 21922-044 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Encube Ethicals Private Limited | ANDA | Current |
| 30142-025 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel, 1% | Kroger Company | ANDA | Current |
| 30142-025 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel, 1% | Kroger Company | ANDA | Current |
| 30142-025 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel, 1% | Kroger Company | ANDA | Current |
| 30142-025 | Diclofenac Sodium Topical Gel 1% | Diclofenac sodium topical gel, 1% | Kroger Company | ANDA | Current |
| 43598-885 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-885 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-885 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-977 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-977 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-977 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 53002-4642 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-863 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Quality Care Products, LLC | ANDA | Current |
| 57896-140 | DICLOFENAC SODIUM | diclofenac sodium topical gel, 1% | GERI-CARE PHARMACEUTICALS CORP | ANDA | Current |
| 63868-730 | DICLOFENAC SODIUM | Diclofenac Sodium topical gel, 1% | Chain Drug Marketing Association INC | ANDA | Current |
| 68071-2239 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2239 | Diclofenac Sodium | Diclofenac Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7772 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7772 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7772 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70512-106 | Diclofenac Sodium | Diclofenac Sodium 1% | SOLA Pharmaceuticals | ANDA | Current |
| 70512-106 | Diclofenac Sodium | Diclofenac Sodium 1% | SOLA Pharmaceuticals | ANDA | Current |
| 70512-106 | Diclofenac Sodium | Diclofenac Sodium 1% | SOLA Pharmaceuticals | ANDA | Current |
| 70518-2813 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | REMEDYREPACK INC. | ANDA | Current |
| 70518-2813 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | REMEDYREPACK INC. | ANDA | Current |
| 70518-2813 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | REMEDYREPACK INC. | ANDA | Current |
| 70518-2813 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | REMEDYREPACK INC. | ANDA | Current |
| 70677-0143 | Arthritis Pain | diclofenac sodium topical gel, 1% | Strategic Sourcing Services, LLC | ANDA | Current |
| 71205-552 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Proficient Rx LP | ANDA | Current |
| 72559-020 | Curist Arthritis Relief | Diclofenac Sodium | Little Pharma, Inc. | ANDA | Current |
| 73715-005 | Diclofenac Sodium Topical Gel, 1% | Diclofenac Sodium Topical Gel, 1% (NSAID) | Mohnark Pharmaceuticals Inc. | ANDA | Current |
| 73715-005 | Diclofenac Sodium Topical Gel, 1% | Diclofenac Sodium Topical Gel, 1% (NSAID) | Mohnark Pharmaceuticals Inc. | ANDA | Current |
| 76420-091 | Diclofenac Sodium | Diclofenac Sodium Topical Gel, 1%, | Asclemed USA, Inc. | ANDA | Current |
| 82226-020 | ValcoPrep-100 | diclofenac sodium, isopropyl alcohol | Plum Valley Pharma LLC | ANDA | Current |
| 82226-020 | ValcoPrep-100 | diclofenac sodium, isopropyl alcohol | Plum Valley Pharma LLC | ANDA | Current |
| 82226-020 | ValcoPrep-100 | diclofenac sodium, isopropyl alcohol | Plum Valley Pharma LLC | ANDA | Current |