FDA.reportPublic FDA data

Application 020254

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VOLTAREN-XRDICLOFENAC SODIUMTABLET, EXTENDED RELEASE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020254-001VOLTAREN-XRDICLOFENAC SODIUM100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0884e616aacf4f…
2026-08-18 06:07:402026-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020254-001VOLTAREN-XR100MGTABLET, EXTENDED RELEASE / ORALRLD1996-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020254-001VOLTAREN-XR100MGTABLET, EXTENDED RELEASE / ORALRLD1996-03-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020254-001VOLTAREN-XR100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD1996-03-08f41ea6bd6efb…

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.

Matched openFDA labels page 12 of 14 · 273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions50efc183-dd3e-4eb7-ba5c-c42fd76e0b652023-12-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUMDICLOFENAC SODIUMProficient Rx LPf19bf286-f4dd-4491-90c3-9f87130719032023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMCVS Pharmacye9ccaf95-582b-4d4d-938f-7577eaa8dffb2023-11-27WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMBryant Ranch Prepacke6a1ff58-a541-46f8-9663-eed53b7cf3922023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions51756947-e802-4b4d-883e-fd6f22e9a7252023-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMA-S Medication Solutions9df87100-acf5-4b46-93b4-067b470136bd2023-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC4808015d-cfee-4f4d-a84b-82099f0b48682023-10-04WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions0379c918-1717-40ab-81cc-268116950fd52023-10-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac sodiumDICLOFENAC SODIUMAsclemed USA, Inc.6a9c3cea-7b46-427d-99af-90c1f290b1902023-09-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
equaline arthritis pain relievingDICLOFENAC SODIUMUnited Natural Foods, Inc. dba UNFI748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d02023-08-23WarningsName fallback
generic name: DICLOFENAC SODIUM
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC2a599579-b2b0-4423-8e30-fe04bf8158702023-08-11WarningsName fallback
generic name: DICLOFENAC SODIUM
Arthritis Pain RelieverDICLOFENAC SODIUMAmerisourceBergen (Good Neighbor Pharmacy) 4612230e1f589-b322-48b7-9a97-502afe2a1baa2023-08-09WarningsName fallback
generic name: DICLOFENAC SODIUM
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsName fallback
generic name: DICLOFENAC SODIUM
berkley and jensen arthritis painDICLOFENAC SODIUMBJWC441cf367-b293-47e8-a8fb-32e3314be7de2023-07-26WarningsName fallback
generic name: DICLOFENAC SODIUM
diclofenac sodiumDICLOFENAC SODIUMBryant Ranch Prepack16853c78-493a-4b8b-87b9-97dc927e1c8e2023-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC SODIUM
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsName fallback
generic name: DICLOFENAC SODIUM
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsName fallback
generic name: DICLOFENAC SODIUM
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsName fallback
generic name: DICLOFENAC SODIUM
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsName fallback
generic name: DICLOFENAC SODIUM
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsName fallback
generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1381Diclofenac SodiumDiclofenac SodiumSandoz IncNDA AUTHORIZED GENERICCurrent
33358-451Diclofenac SodiumDiclofenac SodiumRxChange Co.NDA AUTHORIZED GENERICCurrent
63187-041Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63629-5096Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-5096Diclofenac SodiumDiclofenac SodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68788-9389Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-9389Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67343SUPPL2021-05-03
67342SUPPL2021-05-03
67253SUPPL2021-04-29
43643SUPPL2016-05-18
24665SUPPL2016-05-12
34438SUPPL2016-05-11
41232SUPPL2015-11-05
34437SUPPL2011-03-04
12376SUPPL2011-03-04
24664SUPPL2011-02-28
2251SUPPL2011-02-28
34436SUPPL2009-03-17
24663SUPPL2009-02-27
2250SUPPL2006-01-30
34435SUPPL2006-01-25