FDA.reportPublic FDA data

Application 018310

Type
NDA
Sponsor
COVIDIEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYMPHAZURINISOSULFAN BLUEINJECTABLE;INJECTION1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 44.

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
N018310-001LYMPHAZURINISOSULFAN BLUE50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / SUBCUTANEOUSRLD, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018310-001LYMPHAZURIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018310-001LYMPHAZURIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018310-001LYMPHAZURIN1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018310-001LYMPHAZURIN50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / SUBCUTANEOUSRLD, Approved before 1982a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosulfan BlueISOSULFAN BLUEDevatis, Inc.aa6260da-0acd-4552-a215-07df8da1031c2026-07-01Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUESomerset Therapeutics, LLCa4c7400a-ff36-4a76-aa84-7f91e303f9372026-06-24Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan blueISOSULFAN BLUENovadoz Pharmaceuticals LLC4b7e84ee-f3ba-4b80-86d3-f4debe6a2eca2026-04-29Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUEEugia US LLC42f2d62a-c7f2-4706-87bc-64f3e72d63a92026-02-20Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUEMylan Institutional LLC0391e544-3633-48df-9f3a-ed16183125b12025-12-15Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUEMylan Institutional LLC1878964e-5220-48c8-a872-dcadbc451aff2025-12-15Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUEEugia US LLC61b48ff8-7ace-4ab7-9f58-f250e2830d162024-02-15Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE
Isosulfan BlueISOSULFAN BLUEMeitheal Pharmaceuticals Inc.d36ae5af-6351-497a-9151-82bcb2c62fa02021-10-12Warnings, Adverse reactionsName fallback
generic name: ISOSULFAN BLUE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63261-250LYMPHAZURINisosulfan blueUNITED STATES SURGICAL CORPORATIONNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
14978SUPPL2007-11-08
11203SUPPL2007-11-07