FDA.reportPublic FDA data

Application 077245

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROFLOXACINCIPROFLOXACININJECTABLE;INJECTION200MG/20ML (10MG/ML)NoNo
002CIPROFLOXACINCIPROFLOXACININJECTABLE;INJECTION400MG/40ML (10MG/ML)NoNo

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
A077245-001CIPROFLOXACINCIPROFLOXACIN200MG/20ML (10MG/ML)INJECTABLE / INJECTION2006-08-28
A077245-002CIPROFLOXACINCIPROFLOXACIN400MG/40ML (10MG/ML)INJECTABLE / INJECTION2006-08-28

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 22:54:322026-06A077245-001CIPROFLOXACIN200MG/20ML (10MG/ML)INJECTABLE / INJECTION2006-08-28a50c72e98297…
2026-08-01 22:54:322026-06A077245-002CIPROFLOXACIN400MG/40ML (10MG/ML)INJECTABLE / INJECTION2006-08-28a50c72e98297…

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 8 · 146 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFOLXACINREMEDYREPACK INC.c527d138-e32c-418f-9573-a3d8a796279f2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.c08b37c3-5f01-47ed-9508-02813bbd008b2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEHAWAII REPACK, INC.0fe3becb-f90e-4187-a8e8-bd0de5a79ad22026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
ciprofloxacinCIPROFLOXACINHAWAII REPACK, INC4caf49d9-b06f-4d57-aac3-cc64ae12cc952026-07-12Warnings, Adverse reactionsName fallback
brand name: ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacy348e810c-e572-f3d2-e063-6394a90a08552026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFOLXACINAsclemed USA, Inc.c4eecdf8-9e50-4e44-aca1-b9c19317d52a2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacyc32ccb5f-b9d7-0aff-e053-2995a90afe6d2026-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINRedpharm Drug541bd97e-b2ff-09a8-e063-6394a90aee962026-06-13Warnings, Adverse reactionsName fallback
brand name: ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a2ffa81a-86c5-40b9-8fa0-c889801ef4792026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFOLXACINST. MARY'S MEDICAL PARK PHARMACY24c43000-7620-3869-e063-6394a90a96312026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a914512b-9a4a-4c53-ab7a-2e2b1ea8a0122026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack5af16acc-51ce-41ed-b1c4-6b3fb38ef5152026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka05035e1-f941-4f7c-9321-91dd50ab149b2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.47d1e4c5-f669-4aca-9e8c-0d6bb833b8592026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited6a935846-3c97-4517-bc4e-2377f673285e2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions4dd69fb7-802a-4278-a730-c722a3ca35212026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionsd8b21832-b74f-4f85-a304-b907c9e01e722026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions9d83b127-ef13-4b2c-aa30-0f54937dc2402026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging275de35b-5c97-4ff8-a571-42e23c1cd83e2026-05-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ciprofloxacin

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-914CiprofloxacinCiprofloxacinRebel Distributors CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9025ORIG2006-09-18