Application 207233

Type
NDA
Sponsor
ZYLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIVLODEXMELOXICAMCAPSULE;ORAL5MGYesNo
002VIVLODEXMELOXICAMCAPSULE;ORAL10MGYesYes

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

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
N207233-001VIVLODEXMELOXICAM5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22
N207233-002VIVLODEXMELOXICAM10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207233-00195267342033-03-31Drug product2016-12-30
N207233-00196493182035-03-31Drug product2017-05-16
N207233-00198084682035-03-31U-21602017-11-22
N207233-00198084682035-03-31U-21652017-11-22
N207233-00295267342033-03-31Drug product2016-12-30
N207233-00296493182035-03-31Drug product2017-05-16
N207233-00298084682035-03-31U-21602017-11-22
N207233-00298084682035-03-31U-21652017-11-22

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2284e616aacf4f…
2026-09-14 22:38:342026-08N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2284e616aacf4f…
2026-08-18 06:07:402026-07N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207233-001VIVLODEX5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207233-002VIVLODEX10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2015-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207233-001VIVLODEX5MGCAPSULE / ORALRLD2015-10-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207233-002VIVLODEX10MGCAPSULE / ORALRLD2015-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207233-001VIVLODEX5MGCAPSULE / ORALRLD2015-10-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207233-002VIVLODEX10MGCAPSULE / ORALRLD2015-10-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207233-001VIVLODEX5MGCAPSULE / ORALRLD2015-10-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207233-002VIVLODEX10MGCAPSULE / ORALRLD, RS2015-10-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11N207233-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N207233-002AB1c0c555d07b60…

Observed Orange Book patent history#

Patent history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N207233-00195267342033-03-31Drug product2016-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N207233-00196493182035-03-31Drug product2017-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N207233-00198084682035-03-31U-21652017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N207233-00198084682035-03-31U-21602017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N207233-00295267342033-03-31Drug product2016-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N207233-00296493182035-03-31Drug product2017-05-1684e616aacf4f…
2026-09-14 22:38:342026-08N207233-00298084682035-03-31U-21602017-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N207233-00298084682035-03-31U-21652017-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N207233-00195267342033-03-31Drug product2016-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00196493182035-03-31Drug product2017-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00198084682035-03-31U-21652017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00198084682035-03-31U-21602017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00295267342033-03-31Drug product2016-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00296493182035-03-31Drug product2017-05-16caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00298084682035-03-31U-21602017-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N207233-00298084682035-03-31U-21652017-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207233-00195267342033-03-31Drug product2016-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00196493182035-03-31Drug product2017-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00198084682035-03-31U-21652017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00198084682035-03-31U-21602017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00295267342033-03-31Drug product2016-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00296493182035-03-31Drug product2017-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00298084682035-03-31U-21602017-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207233-00298084682035-03-31U-21652017-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00195267342033-03-31Drug product2016-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00196493182035-03-31Drug product2017-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00198084682035-03-31U-21652017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00198084682035-03-31U-21602017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00295267342033-03-31Drug product2016-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00296493182035-03-31Drug product2017-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00298084682035-03-31U-21602017-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207233-00298084682035-03-31U-21652017-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N207233-00195267342033-03-31Drug product2016-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00196493182035-03-31Drug product2017-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00198084682035-03-31U-21652017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00198084682035-03-31U-21602017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00295267342033-03-31Drug product2016-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00296493182035-03-31Drug product2017-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00298084682035-03-31U-21602017-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207233-00298084682035-03-31U-21652017-11-226a471c1ec25d…

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 2 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELOXICAMMELOXICAMRedpharm Drug5407aded-9f84-72ce-e063-6394a90ae6722026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMSt. Mary's Medical Park Pharmacyfbe71312-0f9d-47c1-e053-6394a90a63a12026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacy60c954d5-bd5a-33f9-e053-2a91aa0ab5972026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMEmerald Therapeutics, LLC55af77dd-2abc-49a6-990c-399d5a5e7a912026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMAvondale Pharmaceuticals, LLC4ddf5a4d-8e84-419d-8e3a-c91b855018852026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMSt. Mary's Medical Park Pharmacy60c9ab35-4b6e-383d-e053-2a91aa0a26ad2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMCoupler LLC52bd9bcd-4902-f9dd-e063-6294a90a604e2026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMREMEDYREPACK INC.fabd063a-d3a5-44a3-90a2-e33d721b7a952026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMProficient Rx LP459bd9c0-1102-46d3-8020-5fec80d1ec362026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.1ab45be4-b2b9-4374-95ab-620e0f90fb702026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.eae60d2c-411c-460a-b673-05b5784ed9432026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMCoupler LLC5071e1fd-5321-42cf-e063-6294a90a0ef62026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMMedcore LLC1160b6a8-d507-40b6-925b-25bf186daa302026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
meloxicamMELOXICAMPD-Rx Pharmaceuticals, Inc.1d8b617a-b9b3-473c-be9b-f34a585a1b3b2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMDirect Rxc172a767-eb26-4995-b2a2-f3c5e87b49432026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMAdvanced Rx of Tennessee, LLCaf9ce58c-3cd7-769f-e053-2a95a90a53852026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MeloxicamMELOXICAMGolden State Medical Supply, Inc.d27feaf7-731e-1a8f-e053-2a95a90afa712026-02-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMA-S Medication Solutionsfe41eca5-33f1-4ded-a177-d8f927f3f2612026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMA-S Medication Solutions2cc0c4c2-eac9-4820-942a-6c606dfb4aa12026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM
MELOXICAMMELOXICAMA-S Medication Solutions7a4212a8-7761-4a77-aa18-ecf1f1244df22026-02-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MELOXICAM

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-205VivlodexmeloxicamIroko Pharmaceuticals, LLNDACurrent
42211-205VivlodexmeloxicamIroko Pharmaceuticals, LLCNDACurrent
42211-206VivlodexmeloxicamIroko Pharmaceuticals, LLNDACurrent
42211-206VivlodexmeloxicamIroko Pharmaceuticals, LLCNDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80400SUPPL 2024-11-25
80399SUPPL 2024-11-25
80317SUPPL 2024-11-22
67379SUPPL2021-05-03
67378SUPPL2021-05-03
67292SUPPL2021-04-30
23033ORIG2016-07-19
32851ORIG2015-10-28
40584ORIG2015-10-27