FDA.reportPublic FDA data

Application 078252

Type
ANDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION200MG/100MLNoNo
002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION400MG/200MLNoNo

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
A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTIONAP2008-03-18
A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTIONAP2008-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078252-001AP
A078252-002AP

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 22:54:322026-06A078252-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18a50c72e98297…
2026-08-01 22:54:322026-06A078252-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078252-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A078252-002AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin in DextroseCIPROFLOXACINProPharma Distribution42c758be-4d44-018a-e063-6294a90ae0412025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
Ciprofloxacin in DextroseCIPROFLOXACINHospira, Inc.cbbbf939-3219-4515-a48e-ca264daa4d072025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
ndc (product): 0409-2300
ndc (product): 0409-3300
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticalsf406e796-17d9-4465-b8a7-00d966a4ba742024-09-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
ndc (product): 25021-192
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticals7049f870-6741-4a67-8033-398c36126a062022-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078252
application number: ANDA078252
ndc (product): 25021-114

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2300Ciprofloxacin in DextroseciprofloxacinHospira, IncANDACurrent
0409-3300Ciprofloxacin in DextroseciprofloxacinHospira, IncANDACurrent
0781-3239CiprofloxacinCiprofloxacinSandoz IncANDACurrent
0781-3240CiprofloxacinCiprofloxacinSandoz IncANDACurrent
25021-114CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent
25021-114CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent
25021-114CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent
25021-114CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent
25021-114CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent
25021-192CiprofloxacinciprofloxacinSagent PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31351ORIG2008-03-19