FDA.reportPublic FDA data

Application 063206

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHOTERICIN BAMPHOTERICIN BINJECTABLE;INJECTION50MG/VIALNoYes

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
A063206-001AMPHOTERICIN BAMPHOTERICIN B50MG/VIALINJECTABLE / INJECTIONRS1992-04-29

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 UTC2022-10A063206-001AMPHOTERICIN B50MG/VIALINJECTABLE / INJECTIONRS1992-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A063206-001AMPHOTERICIN B50MG/VIALINJECTABLE / INJECTIONRS1992-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A063206-001AMPHOTERICIN B50MG/VIALINJECTABLE / INJECTIONRS1992-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A063206-001AMPHOTERICIN B50MG/VIALINJECTABLE / INJECTIONRS1992-04-29a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphotericin BAMPHOTERICIN BXGen Pharmaceuticals DJB, Inc.a0a54943-9ce4-4f3e-b681-a1a9144c16ce2022-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063206
application number: ANDA063206
ndc (product): 39822-1055

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-1055Amphotericin BAmphotericin BX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-1055Amphotericin BAmphotericin BX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-1055Amphotericin BAmphotericin BXGen Pharmaceuticals DJB, Inc.ANDACurrent