FDA.reportPublic FDA data

Application 073617

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATEINJECTABLE;INJECTION300MG/VIALNoNo

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
A073617-001PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATE300MG/VIALINJECTABLE / INJECTION1995-12-18

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 UTC2022-10A073617-001PENTAMIDINE ISETHIONATE300MG/VIALINJECTABLE / INJECTION1995-12-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073617-001PENTAMIDINE ISETHIONATE300MG/VIALINJECTABLE / INJECTION1995-12-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073617-001PENTAMIDINE ISETHIONATE300MG/VIALINJECTABLE / INJECTION1995-12-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073617-001PENTAMIDINE ISETHIONATE300MG/VIALINJECTABLE / INJECTION1995-12-18a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentamidine IsethionatePENTAMIDINE ISETHIONATEPAI Holdings, LLC dba PAI Pharma4c01d8e9-a25b-4046-8924-53bd9acd560d2026-06-12Warnings, Adverse reactionsName fallback
brand name: Pentamidine Isethionate
generic name: PENTAMIDINE ISETHIONATE
Pentamidine IsethionatePENTAMIDINE ISETHIONATEPAI Holdings, LLC dba PAI Pharmad46aea4f-8f3f-4ce0-93d6-94e147f5a31a2026-05-07Warnings, Adverse reactionsName fallback
brand name: Pentamidine Isethionate
generic name: PENTAMIDINE ISETHIONATE
pentamidine isethionatePENTAMIDINE ISETHIONATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5c14fbf2-e21f-44b3-b35c-06919d40d7e02025-10-31Warnings, Adverse reactionsName fallback
brand name: pentamidine isethionate
generic name: PENTAMIDINE ISETHIONATE
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalsc484f16e-9d97-4416-84a4-8ad8deaf5e192025-04-08Warnings, Adverse reactionsName fallback
brand name: Pentamidine Isethionate
generic name: PENTAMIDINE ISETHIONATE
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalscb8e8155-5505-44d5-9dee-525e2e45b95d2025-04-02Warnings, Adverse reactionsName fallback
brand name: Pentamidine Isethionate
generic name: PENTAMIDINE ISETHIONATE
NebuPentPENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCe2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb2024-10-15Warnings, Adverse reactionsName fallback
generic name: PENTAMIDINE ISETHIONATE
Pentam 300PENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCcc2b635e-4840-4dc3-a177-5484371680e82022-09-13Warnings, Adverse reactionsName fallback
generic name: PENTAMIDINE ISETHIONATE

Reported adverse events (FAERS/openFDA)#

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