Application 204592

Type
NDA
Sponsor
ZYLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZORVOLEXDICLOFENACCAPSULE;ORAL18MGYesNo
002ZORVOLEXDICLOFENACCAPSULE;ORAL35MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204592-001ZORVOLEXDICLOFENAC18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18
N204592-002ZORVOLEXDICLOFENAC35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204592-00186795442030-04-23Drug product2014-03-25
N204592-00189993872030-04-23U-552015-04-07
N204592-00190177212030-04-23Drug product2015-04-29
N204592-00191738542030-04-23Drug product2015-11-05
N204592-00191800952030-04-23U-552015-11-12
N204592-00191800962030-04-23Drug product2015-11-12
N204592-00191863282030-04-23U-552015-11-19
N204592-00286795442030-04-23Drug product2014-03-25
N204592-00289993872030-04-23U-552015-04-07
N204592-00290177212030-04-23Drug product2015-04-29
N204592-00291738542030-04-23Drug product2015-11-05
N204592-00291800952030-04-23U-552015-11-12
N204592-00291800962030-04-23Drug product2015-11-12
N204592-00291863282030-04-23U-552015-11-19

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204592-002ZORVOLEX35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204592-001ZORVOLEX18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2013-10-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N204592-002ZORVOLEX35MGCAPSULE / ORALRLD2013-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204592-001ZORVOLEX18MGCAPSULE / ORALRLD2013-10-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204592-002ZORVOLEX35MGCAPSULE / ORALRLD, RS2013-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204592-001ZORVOLEX18MGCAPSULE / ORALRLD2013-10-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N204592-002ZORVOLEX35MGCAPSULE / ORALRLD, RS2013-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204592-001ZORVOLEX18MGCAPSULE / ORALRLD2013-10-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N204592-002ZORVOLEX35MGCAPSULE / ORALRLD, RS2013-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204592-001ZORVOLEX18MGCAPSULE / ORALRLD2013-10-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204592-002ZORVOLEX35MGCAPSULE / ORALRLD, RS2013-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204592-001ZORVOLEX18MGCAPSULE / ORALRLD2013-10-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N204592-002ZORVOLEX35MGCAPSULE / ORALRLD, RS2013-10-18bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204592-00186795442030-04-23Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00189993872030-04-23U-552015-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00190177212030-04-23Drug product2015-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00191738542030-04-23Drug product2015-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00191800952030-04-23U-552015-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00191800962030-04-23Drug product2015-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00191863282030-04-23U-552015-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00286795442030-04-23Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00289993872030-04-23U-552015-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00290177212030-04-23Drug product2015-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00291738542030-04-23Drug product2015-11-05caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00291800952030-04-23U-552015-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00291800962030-04-23Drug product2015-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N204592-00291863282030-04-23U-552015-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204592-00186795442030-04-23Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00189993872030-04-23U-552015-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00190177212030-04-23Drug product2015-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00191738542030-04-23Drug product2015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00191800952030-04-23U-552015-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00191800962030-04-23Drug product2015-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00191863282030-04-23U-552015-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00286795442030-04-23Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00289993872030-04-23U-552015-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00290177212030-04-23Drug product2015-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00291738542030-04-23Drug product2015-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00291800952030-04-23U-552015-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00291800962030-04-23Drug product2015-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N204592-00291863282030-04-23U-552015-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00186795442030-04-23Drug product2014-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00189993872030-04-23U-552015-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00190177212030-04-23Drug product2015-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00191738542030-04-23Drug product2015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00191800952030-04-23U-552015-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00191800962030-04-23Drug product2015-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00191863282030-04-23U-552015-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00286795442030-04-23Drug product2014-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00289993872030-04-23U-552015-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00290177212030-04-23Drug product2015-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00291738542030-04-23Drug product2015-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204592-00291800952030-04-23U-552015-11-1231067a03dcf5…

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 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENACPreferred Pharmaceuticals Inc.937e9ba5-cdad-4e72-a77a-bad699e1b2362026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
XicloDICLOFENACStrand Health Group2d93a01c-40a9-8fb0-e063-6394a90a2cc62025-12-18WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACPHOENIX RX LLC41dab520-5651-a4c5-e063-6394a90a29622025-10-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
XicloDICLOFENACAsclemed USA, Inc.71cd0d4e-671c-4372-9b1f-7b34cf8878242025-06-07WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC45321aec-368d-4ca4-a0c5-2ce56fae74b22025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac DRDICLOFENACAdvanced Rx of Tennessee, LLCaf8a30fb-ead8-7e29-e053-2a95a90a040f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAdvanced Rx Pharmacy of Tennessee, LLCfc100cb2-16d9-f67d-e053-6294a90a0f2e2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAmneal Pharmaceuticals LLC78873f83-cea9-44d4-8ad4-8cb9257e5c7f2024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac sodiumDICLOFENACAmneal Pharmaceuticals NY LLC1084e0c3-6d75-4090-84dc-02a18e0299b92023-12-29WarningsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACProficient Rx LPf4da38af-c5bd-4d4a-a6f3-c2933f2238092023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACBryant Ranch Prepacke5f8284a-1aa9-4a36-a6ad-fa153c613f342023-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACA-S Medication Solutions58178f0d-3960-48e3-91ba-150f691be2412023-05-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC
Diclofenac SodiumDICLOFENACAsclemed USA, Inc.9df599de-6412-a94e-e053-2995a90a17412022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DICLOFENAC

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-203ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-203ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-204ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-204ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
69344-203ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-203ZorvolexdiclofenacEgalet US Inc.NDACurrent
69344-203ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-204ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-204ZorvolexdiclofenacEgalet US Inc.NDACurrent
69344-204ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
73480-242DICLOFENACDiclofenacTriVue Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80394SUPPL 2024-11-25
80393SUPPL 2024-11-25
80313SUPPL 2024-11-22
67360SUPPL2021-05-03
67359SUPPL2021-05-03
67285SUPPL2021-04-30
52767SUPPL2018-02-28
52766SUPPL2018-02-28
40397SUPPL2016-05-11
19575SUPPL2016-05-11
10362SUPPL2016-05-10
10361SUPPL2016-05-10
32570SUPPL2014-08-27
10360SUPPL2014-08-27
19574SUPPL2014-08-26
19573SUPPL2014-08-26
24472ORIG2014-03-26
22959ORIG2014-03-26
23515ORIG2013-10-24
19572ORIG2013-10-22
10359ORIG2013-10-22