Application 208786
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | SOLUTION;INTRAVENOUS | 37.5MG/ML (37.5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208786-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 |
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 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208786-001 | DICLOFENAC SODIUM | 37.5MG/ML (37.5MG/ML) | SOLUTION / INTRAVENOUS | 2019-06-18 | f41ea6bd6efb… |
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 TOPICAL | DICLOFENAC SODIUM | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 181e32ab-5ec0-4be4-bad0-b6bbafc08f85 | 2026-01-15 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sportpharm LLC | 929f71ab-f0c8-4331-800d-ed4a172e647e | 2026-01-14 | Warnings | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Sportpharm LLC | ac631742-119f-408a-8b36-b041bab743e2 | 2026-01-14 | Warnings | Diclofenac sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | AvKARE | 19b4ff5c-adb7-a0d0-7ef2-4ae05047fd94 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | AvKARE | 0416ce03-c345-9d9e-e063-6294a90ad940 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Diclofenac sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM 1% | Asclemed USA, Inc. | 6952a221-17fd-4592-8edc-ff3699743533 | 2026-01-13 | Warnings | Diclofenac Sodium |
| Aspercreme Arthritis | DICLOFENAC SODIUM | Chattem, Inc. | 81f78685-c416-48b5-8840-eef03a66bc28 | 2026-01-12 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | REMEDYREPACK INC. | 14c1b1a1-bc06-4722-9612-e88ae52272bc | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 1e669fc2-69bf-4439-a336-a103e5b9cafe | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 8825dc2c-3497-455f-b5e1-2aa667291957 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | PHOENIX RX LLC | 47ce6fab-be1d-0076-e063-6294a90add63 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Arthritis Pain Reliever | DICLOFENAC SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 98f94aa2-6bc2-4c07-81c8-63b2c262cf39 | 2026-01-06 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Northwind Health Company, LLC | c16e7e43-3869-9fef-e053-2995a90a1fdb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Northwind Health Company, LLC | f2b7ea75-738b-54a8-e053-2995a90a00d5 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 47a7a294-55bb-8d19-e063-6394a90a5440 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 40388047-7fbe-49bf-bed8-e5087bed4e03 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 4a88f136-f7c7-47d7-b85d-8a2f9f118f09 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Safeway, Inc. | 196d8af7-739f-4d2c-8c4e-9d33e6d722ab | 2025-12-23 | Warnings | Diclofenac sodium DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Redpharm Drug | 325213a3-241c-18d2-e063-6394a90a40f7 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Diclofenac Sodium DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | A-S Medication Solutions | 58063c26-86fe-4f03-97ef-51706e5f4054 | 2025-12-16 | 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 |
|---|---|---|
| 59237 | ORIG | 2019-07-05 |