Application 208021
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | SOLUTION;TOPICAL | 2% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208021-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208021-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | 2022-09-20 | f41ea6bd6efb… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208021-001 | DICLOFENAC SODIUM | 2% | SOLUTION / TOPICAL | AB | RS | 2022-09-20 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208021-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208021-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208021-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208021-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208021-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208021-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208021-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208021-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208021-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208021-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208021-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208021-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208021-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208021-001 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208021-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208021-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208021-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208021-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208021-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208021-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208021-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208021-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208021-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208021-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208021-001 | AB | 1 | f41ea6bd6efb… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208021-001 | AB | 1 | 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 | ASCLEMED USA INC. | 53e8ad44-ff67-d3bb-e063-6394a90a524d | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Preferred Pharmaceuticals Inc. | e042e64c-5f18-4483-bcbd-dfd9b08a81cf | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium Topical Solution | DICLOFENAC SODIUM TOPICAL SOLUTION | Direct_Rx | 223f0fb4-2006-c2dd-e063-6394a90a563a | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Lupin Pharmaceuticals, Inc. | 609c5344-9c97-4fa8-ad53-d0f622ce64ec | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium | DICLOFENAC SODIUM | PHOENIX RX LLC | 3a4f7301-aa1c-9064-e063-6294a90a6eb4 | 2025-07-21 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 898558e7-17f8-40cd-9dfc-67ddd64a5a42 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 1be247b8-dafd-ddf9-e063-6294a90aa9e1 | 2024-06-27 | Boxed warning, Warnings, Adverse reactions | 208021 ANDA208021 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54444 | ORIG | 2018-06-05 |