Application 019201
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | VOLTAREN | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N019201-001 | VOLTAREN | DICLOFENAC SODIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |
| N019201-002 | VOLTAREN | DICLOFENAC SODIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |
| N019201-003 | VOLTAREN | DICLOFENAC SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 |
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| 2026-08 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019201-002 | VOLTAREN | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019201-003 | VOLTAREN | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 301d65b070ca… |
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.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67339 | SUPPL | 2021-05-03 |
| 67338 | SUPPL | 2021-05-03 |
| 67249 | SUPPL | 2021-04-29 |
| 1251 | SUPPL | 2016-05-12 |
| 33706 | SUPPL | 2016-05-11 |
| 33705 | SUPPL | 2011-03-04 |
| 11450 | SUPPL | 2011-03-04 |
| 16213 | SUPPL | 2011-02-28 |
| 1250 | SUPPL | 2011-02-28 |
| 23132 | ORIG | 2009-12-04 |
| 33704 | SUPPL | 2009-03-17 |
| 16212 | SUPPL | 2009-02-27 |
| 1249 | SUPPL | 2007-07-16 |
| 11449 | SUPPL | 2007-07-10 |
| 16211 | SUPPL | 2006-01-30 |
| 33703 | SUPPL | 2006-01-25 |
| 20213 | SUPPL | 2005-02-08 |
| 1248 | SUPPL | 2002-11-26 |