FDA.reportPublic FDA data

Application 061578

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLY-RXPOLYMYXIN B SULFATEPOWDER;FOR RX COMPOUNDING100,000,000 UNITS/BOTNoNo

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
A061578-001POLY-RXPOLYMYXIN B SULFATE100,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved 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 UTC2022-10A061578-001POLY-RX100,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061578-001POLY-RX100,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061578-001POLY-RX100,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061578-001POLY-RX100,000,000 UNITS/BOTPOWDER / FOR RX COMPOUNDINGApproved 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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polymyxin BPOLYMYXIN B SULFATEXellia Pharmaceuticals USA LLCb56f18c0-ef5e-4ed9-a5af-f79f3cd189b62026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
Polymyxin BPOLYMYXIN B SULFATESagent Pharmaceuticals7dc505aa-64b0-4b7f-8ee3-2945bde40a342025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
POLYMYXIN BPOLYMYXIN B SULFATEFOSUN PHARMA USA INCfd664927-db58-a1af-e053-6294a90a90482025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.d2bf65f6-2763-4859-a665-ad5e6cde71ee2025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
POLYMYXIN BPOLYMYXIN B SULFATEGland Pharma Limiteddc74dee2-1d0b-4fab-a29b-1755fdb5da752025-05-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
Polymyxin BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC72dd6de6-31d6-4a8f-881b-91af91ed93142022-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
Polymyxin BPOLYMYXIN B SULFATEHikma Pharmaceuticals USA Inc.18daf0d1-b6f5-46f4-ab2f-01a594f3959c2022-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLC704a41f5-b109-4c16-8d3e-1495c99179522021-05-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCfbc12c18-567b-41bc-89d0-efd29616615c2021-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: POLYMYXIN B SULFATE

Reported adverse events (FAERS/openFDA)#

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