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SODIUM | TABLET, EXTENDED RELEASE;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| VOLTAREN-XR | DICLOFENAC SODIUM | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 |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| 2026-08 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 84e616aacf4f… | |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| 2026-07 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | caaa826d4ba7… | |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UTC | 2026-02 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 011fe1cb6892… | |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ZIP | 2025-12 | N020254-001 | VOLTAREN-XR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1996-03-08 | 31067a03dcf5… | |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 |
|---|---|---|---|---|---|---|
| Diclofenac Sodium | DICLOFENAC SODIUM | NorthStar Rx LLC | fd467c1a-6463-4d92-9960-3e308c733edb | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | 5b4c1a15-ed93-7192-e053-2991aa0a8360 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals,Inc. | ad193f94-f8d0-8482-e053-2995a90a35a4 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | b3dbd981-453c-645f-e053-2a95a90aec3c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 0803345d-7811-bc21-e063-6394a90aa661 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | d424ab84-2aaa-38a9-e053-2a95a90adde9 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | ec06cca5-3436-10c8-e053-2995a90a4aeb | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium ER | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | ecaa39b8-067c-80d7-e053-2a95a90a7354 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | f1892aae-7267-3b4c-e053-2995a90a8802 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | f1896c84-b18a-d49d-e053-2995a90aaab3 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | f1892aae-7264-3b4c-e053-2995a90a8802 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | f3d27ae6-1259-5375-e053-2995a90a572d | 2024-12-31 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | f187ae44-71be-a682-e053-2995a90a6426 | 2024-12-31 | Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | fc0e1950-d76f-75bc-e053-6294a90a8c12 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium DR | DICLOFENAC SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | af8a1392-67e8-8201-e053-2a95a90a0fce | 2024-12-30 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Quality Care Products, LLC | 3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Quality Care Products, LLC | 12e1f808-9f24-4f6d-b5bc-12ce0059ab7a | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | f18a4691-93a1-01e6-e053-2995a90a0069 | 2024-12-05 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | NuCare Pharmaceuticals, LLC. | 26e44aa5-cfcd-f10b-e063-6394a90a4dcf | 2024-11-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Salonpas | DICLOFENAC SODIUM | Hisamitsu America, Inc. | f439445d-046e-4220-a4a7-13d750ee0949 | 2024-11-14 | Warnings | 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 |