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SODIUM | TABLET, DELAYED RELEASE;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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SODIUM | TABLET, DELAYED RELEASE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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SODIUM | TABLET, DELAYED RELEASE;ORAL | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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N019201-001 | VOLTAREN | DICLOFENAC SODIUM | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |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N019201-002 | VOLTAREN | DICLOFENAC SODIUM | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | |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N019201-003 | VOLTAREN | DICLOFENAC SODIUM | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 |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| 2026-08 | N019201-001 | VOLTAREN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 1988-07-28 | 84e616aacf4f… | |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 |
|---|---|---|---|---|---|---|
| MEMBERS MARK ARTHRITIS PAIN RELIEVER | DICLOFENAC SODIUM | Sam's West Inc | d339aaa2-ae7e-4a79-b687-cf0a3106fad0 | 2025-07-16 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Golden State Medical Supply, Inc. | 39e67a90-df3e-ad30-e063-6394a90a7a82 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sun Pharmaceutical Industries, Inc. | f9a0c654-5f77-430f-b921-295eb776cbcd | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advagen Pharma Ltd | ac2b4060-a5da-4ddf-a734-2ff58a1f98c9 | 2025-07-03 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | Sun Pharmaceutical Industries, Inc. | aa1e1ed3-0444-4bf5-a0ee-5d21a7fca391 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Arthritis Pain Reliever | DICLOFENAC SODIUM | Chain Drug Consortium, LLC | 8879a2ed-6c66-4489-8adc-9f160241cc7d | 2025-06-25 | Warnings | DICLOFENAC SODIUM |
| kirkland signature arthritis pain relief | DICLOFENAC SODIUM | Costco Wholesale Company | c30353da-acd6-474f-8a64-abd078bf4f85 | 2025-06-11 | Warnings | DICLOFENAC SODIUM |
| members mark arthritis pain reliever | DICLOFENAC SODIUM | Sam's West Inc | 44533b5b-73ce-4853-9eda-506426cb9b82 | 2025-06-09 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 363764a0-e0a8-3e3f-e063-6294a90ad672 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium Delayed Release | DICLOFENAC SODIUM | Carlsbad Technology, Inc. | 40879600-ba6c-43a8-aa5d-d0d41503d593 | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Aurobindo Pharma Limited | 3487033c-7c62-4034-8718-73a7c49b26a0 | 2025-05-09 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | PD-Rx Pharmaceuticals, Inc. | 87d5a720-f154-4c4b-b2d4-0ae58455dda0 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac sodium | DICLOFENAC SODIUM | BluePoint Laboratories | 896e3f7d-88e6-4563-b879-a2757d19fd62 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | Advagen Pharma Ltd | 72419a68-4c9d-44e0-9b43-922440e2c8d7 | 2025-04-30 | Warnings, Adverse reactions | DICLOFENAC SODIUM |
| up and up arthritis pain reliever | DICLOFENAC SODIUM | Target Corporation | 0b7ae58c-cdaf-4343-a199-7a90bf901eb5 | 2025-04-27 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | NorthStar Rx LLC | c7431496-c0ef-403a-9716-92d942709b3d | 2025-04-25 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | GERI-CARE PHARMACEUTICAL CORP | fc08e58c-6323-e667-e053-6394a90ab754 | 2025-04-21 | Warnings | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | RedPharm Drug, Inc. | 4ecb7bdc-4a5e-7444-e054-00144ff88e88 | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| Diclofenac Sodium | DICLOFENAC SODIUM | Bryant Ranch Prepack | 487fa223-f4d9-4ab1-a5af-fb0d93f2bd0e | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | DICLOFENAC SODIUM |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | INNOVUS PHARMACEUTICALS, INC. | ad9d2c28-21bc-4f81-9c90-cce6a96d976a | 2025-03-25 | 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 |