FDA.reportPublic FDA data

Application 076488

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESNAMESNAINJECTABLE;INTRAVENOUS100MG/MLNoNo

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
A076488-001MESNAMESNA100MG/MLINJECTABLE / INTRAVENOUS2012-03-08

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 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 UTC2022-10A076488-001MESNA100MG/MLINJECTABLE / INTRAVENOUS2012-03-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076488-001MESNA100MG/MLINJECTABLE / INTRAVENOUS2012-03-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076488-001MESNA100MG/MLINJECTABLE / INTRAVENOUS2012-03-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076488-001MESNA100MG/MLINJECTABLE / INTRAVENOUS2012-03-08a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MESNAMESNAEugia US LLC49e9c804-9e88-4774-8faf-35bd61b3a8e92026-01-27Warnings, Adverse reactionsName fallback
brand name: MESNA
generic name: MESNA
MESNEXMESNABamboo US Bidco LCC1dd69e84-616d-fb77-e063-6394a90af2f42025-12-10Warnings, Adverse reactionsName fallback
generic name: MESNA
MesnaMESNASagent Pharmaceuticals2a2a526f-636b-7920-4261-6c626f612a2a2025-03-02Warnings, Adverse reactionsName fallback
brand name: Mesna
generic name: MESNA
MESNAMESNAIngenus Pharmaceuticals, LLC90d64539-33ad-47e8-9de7-17d6c5baaba42025-01-16Warnings, Adverse reactionsName fallback
brand name: MESNA
generic name: MESNA
MesnaMESNAFresenius Kabi USA, LLCef161ede-0451-43c8-b0e5-cb108b138e382024-10-15Warnings, Adverse reactionsName fallback
brand name: Mesna
generic name: MESNA
mesnaMESNAHikma Pharmaceuticals USA Inc.8012b97b-4e39-451f-8e04-542d196e8bc62023-05-03Warnings, Adverse reactionsName fallback
brand name: mesna
generic name: MESNA
MesnaMESNA INJECTIONGland Pharma Limiteda7af968c-05cf-4438-94ba-96a2baf9c3672022-10-07Warnings, Adverse reactionsName fallback
brand name: Mesna
MESNEXMESNABaxter Healthcare Company4a51ffdb-f59f-4e02-b3c4-f3457ab7b5142019-12-21Warnings, Adverse reactionsName fallback
generic name: MESNA
MESNEXMESNABaxter Healthcare Company49fdfbc3-69f8-4706-9d11-bf60e4e7811b2018-12-17Warnings, Adverse reactionsName fallback
generic name: MESNA
MESNAMESNABaxter Healthcare Companyfe1683ef-0569-411e-8188-0499884632ad2018-12-17Warnings, Adverse reactionsName fallback
brand name: MESNA
generic name: MESNA
MESNAMESNABaxter Healthcare Companya880160b-fa82-453a-a971-29ab897876a72018-12-17Warnings, Adverse reactionsName fallback
brand name: MESNA
generic name: MESNA
MESNEXMESNABaxter Healthcare Company2e8eebc3-ea75-4c57-bfe1-2c5dc2c378062018-07-24Warnings, Adverse reactionsName fallback
generic name: MESNA

Reported adverse events (FAERS/openFDA)#

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