FDA.reportPublic FDA data

Application 079104

Type
ANDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoYes
002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)NoYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079104-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAPRS2009-07-30
A079104-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAPRS2009-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A079104-001AP
A079104-002AP

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 22:54:322026-06A079104-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAPRS2009-07-30a50c72e98297…
2026-08-01 22:54:322026-06A079104-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAPRS2009-07-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079104-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A079104-002AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLEHospira, Inc22ebc3fb-ee81-44bd-a6e3-5e759ee724a82024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079104
application number: ANDA079104
FluconazoleFLUCONAZOLESagent Pharmaceuticals02f74fe7-0649-46c5-a06a-0700cd2657732024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079104
application number: ANDA079104
ndc (product): 25021-184
FluconazoleFLUCONAZOLESagent Pharmaceuticalsc041227b-dab6-4c29-ab59-d31993d524b22024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079104
application number: ANDA079104
ndc (product): 25021-184

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-113FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-113FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent
25021-184FluconazoleFluconazoleSagent PharmaceuticalsANDACurrent