FDA.reportPublic FDA data

Application 087409

Type
ANDA
Sponsor
LUITPOLD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MANNITOL 25%MANNITOLINJECTABLE;INJECTION12.5GM/50MLNoNo

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
A087409-001MANNITOL 25%MANNITOL12.5GM/50MLINJECTABLE / INJECTION1982-01-21

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A087409-001MANNITOL 25%12.5GM/50MLINJECTABLE / INJECTION1982-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087409-001MANNITOL 25%12.5GM/50MLINJECTABLE / INJECTION1982-01-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087409-001MANNITOL 25%12.5GM/50MLINJECTABLE / INJECTION1982-01-21a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aridol Bronchial Challenge Test KitMANNITOLMethapharm, Inc.5387a4fb-b894-4cba-88a3-a947217d34da2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsName fallback
generic name: MANNITOL
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsName fallback
generic name: MANNITOL
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsName fallback
generic name: MANNITOL

Reported adverse events (FAERS/openFDA)#

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