Application 077753

Type
ANDA
Sponsor
HOSPIRA

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18
A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077753-001AP
A077753-002AP

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077753-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAPRS2008-03-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077753-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAPRS2008-03-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077753-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077753-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077753-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077753-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077753-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077753-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077753-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077753-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077753-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077753-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077753-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077753-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077753-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077753-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077753-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077753-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077753-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077753-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077753-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077753-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077753-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077753-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077753-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077753-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077753-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077753-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077753-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077753-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077753-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077753-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077753-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077753-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077753-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077753-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077753-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077753-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077753-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077753-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077753-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077753-002AP1bb7c543d1eb4…

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 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.44b6cefc-7638-4437-95e7-8f239f66a9d42026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.c08b37c3-5f01-47ed-9508-02813bbd008b2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINHAWAII REPACK, INC4caf49d9-b06f-4d57-aac3-cc64ae12cc952026-07-12Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacy348e810c-e572-f3d2-e063-6394a90a08552026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINSt. Mary's Medical Park Pharmacyc32ccb5f-b9d7-0aff-e053-2995a90afe6d2026-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINRedpharm Drug541bd97e-b2ff-09a8-e063-6394a90aee962026-06-13Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack5af16acc-51ce-41ed-b1c4-6b3fb38ef5152026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka05035e1-f941-4f7c-9321-91dd50ab149b2026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINPreferred Pharmaceuticals Inc.18414c5a-8153-44f7-b27a-90c290af0a232026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.c2d8dcc9-23b0-75bb-e053-2995a90a02c82026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.3b9b15f7-354b-4049-982b-f6f31751a8852026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINDirect_Rx351b41db-622f-a1eb-e063-6294a90a56672026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf52e242-199b-4206-e053-2a95a90a1eb72026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.bf8d4359-a850-97b7-e053-2a95a90aa66a2026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiproCIPROFLOXACIN HYDROCHLORIDEBayer HealthCare Pharmaceuticals Inc.888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c02026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINSportpharm LLC190395a8-c05f-4e31-9a89-7af6428ebbb92026-02-05Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINDirect_Rx36d6c27d-45dc-3081-e063-6394a90a87e92026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
0409-4777CIPROFLOXACINCIPROFLOXACINHospira, Inc.ANDACurrent
55154-7828CIPROFLOXACINCIPROFLOXACINCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9078ORIG2008-03-19