Application 020254
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOLTAREN-XR | DICLOFENAC SODIUM | TABLET, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020254-001 | VOLTAREN-XR | DICLOFENAC SODIUM | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 |
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| 2026-08 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020254-001 | VOLTAREN-XR | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020254-001 | VOLTAREN-XR | 100MG | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 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 |
|---|---|---|---|---|---|---|
| basic care arthritis pain | DICLOFENAC SODIUM | Amazon.com Services LLC | a8aa9016-bf2d-4727-9184-512b2570000b | 2022-01-06 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sandoz Inc | 52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b | 2021-09-29 | Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Actavis Pharma, Inc. | a57b897e-0cbe-4ac3-969f-b00357a0cfa8 | 2021-08-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 2021-01-21 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Asclemed USA, Inc. | 57d8513a-820a-46c5-b0c8-5aa1811b0e88 | 2020-10-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 20107264-e533-4de9-9a37-59fde7981c92 | 2020-09-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 1e39f8d4-56a2-4d29-a971-495574e8d4a7 | 2020-06-17 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 7bc185e2-e749-4a24-8550-c2f6d39222d2 | 2020-04-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Proficient Rx LP | b0f9e649-6651-406f-a9fe-157fe04d9d27 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | a7447467-79e0-436e-a273-d1ddd06169cf | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 77c3cb56-c071-4d92-a0d6-022417a27de4 | 2019-11-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Aphena Pharma Solutions - Tennessee, LLC | e4af374a-1281-46af-a0a9-48820db6c947 | 2018-05-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Novel Laboratories, Inc. | c99f5ef6-c777-4896-a5e7-7335257439b2 | 2016-06-16 | 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 |
|---|---|---|---|---|---|
| 0781-1381 | Diclofenac Sodium | Diclofenac Sodium | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 33358-451 | Diclofenac Sodium | Diclofenac Sodium | RxChange Co. | NDA AUTHORIZED GENERIC | Current |
| 63187-041 | Diclofenac Sodium | Diclofenac Sodium | Proficient Rx LP | ANDA | Current |
| 63629-5096 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 63629-5096 | Diclofenac Sodium | Diclofenac Sodium | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 68788-9389 | Diclofenac Sodium | Diclofenac Sodium | Preferred Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68788-9389 | Diclofenac Sodium | Diclofenac Sodium | Preferred Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67343 | SUPPL | 2021-05-03 |
| 67342 | SUPPL | 2021-05-03 |
| 67253 | SUPPL | 2021-04-29 |
| 43643 | SUPPL | 2016-05-18 |
| 24665 | SUPPL | 2016-05-12 |
| 34438 | SUPPL | 2016-05-11 |
| 41232 | SUPPL | 2015-11-05 |
| 34437 | SUPPL | 2011-03-04 |
| 12376 | SUPPL | 2011-03-04 |
| 24664 | SUPPL | 2011-02-28 |
| 2251 | SUPPL | 2011-02-28 |
| 34436 | SUPPL | 2009-03-17 |
| 24663 | SUPPL | 2009-02-27 |
| 2250 | SUPPL | 2006-01-30 |
| 34435 | SUPPL | 2006-01-25 |