FDA.reportPublic FDA data

Application 050724

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABELCETAMPHOTERICIN BINJECTABLE, LIPID COMPLEX;INJECTION5MG/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050724-001ABELCETAMPHOTERICIN B5MG/MLINJECTABLE, LIPID COMPLEX / INJECTIONRLD1995-11-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050724-001ABELCET5MG/MLINJECTABLE, LIPID COMPLEX / INJECTIONRLD1995-11-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphotericin BAMPHOTERICIN BSun Pharmaceutical Industries, Inc.02aadef1-390b-4270-b56d-33452eb89dde2026-04-20Warnings, Adverse reactionsName fallback
generic name: AMPHOTERICIN B
Amphotericin BAMPHOTERICIN BSun Pharmaceutical Industries, Inc.593cffa0-c305-48b6-8ec7-331e0ff91d2b2026-04-20Warnings, Adverse reactionsName fallback
generic name: AMPHOTERICIN B
Amphotericin BAMPHOTERICIN BEugia US LLC6f24975c-5191-4fc2-a8da-e57358f8e1542025-06-12Warnings, Adverse reactionsName fallback
generic name: AMPHOTERICIN B
Amphotericin BAMPHOTERICIN BHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2b2f3ff5-9d62-4ad2-8eac-1181e59115132025-06-03Warnings, Adverse reactionsName fallback
generic name: AMPHOTERICIN B
Amphotericin BAMPHOTERICIN BXGen Pharmaceuticals DJB, Inc.a0a54943-9ce4-4f3e-b681-a1a9144c16ce2022-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHOTERICIN B

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent
57665-101ABELCETamphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl-Leadiant Biosciences, Inc.NDACurrent