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SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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N019201-001 | VOLTAREN | DICLOFENAC SODIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |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N019201-002 | VOLTAREN | DICLOFENAC SODIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |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N019201-003 | VOLTAREN | DICLOFENAC SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 |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| 2026-08 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 84e616aacf4f… | |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 |
|---|---|---|---|---|---|---|
| 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.
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 |