Application 078024

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

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 43.

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
A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100MLINJECTABLE / INJECTION2008-03-18
A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200MLINJECTABLE / INJECTION2008-03-18

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTION2008-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTION2008-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078024-001CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONAP2008-03-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078024-002CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONAP2008-03-1874a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078024-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078024-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078024-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078024-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078024-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078024-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078024-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078024-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078024-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078024-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078024-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078024-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078024-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078024-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078024-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078024-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078024-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078024-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078024-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078024-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078024-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078024-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078024-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078024-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078024-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078024-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078024-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078024-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078024-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078024-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078024-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078024-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078024-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078024-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078024-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078024-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078024-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A078024-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078024-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078024-002AP1b00525d2431f…

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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.641729a3-6dd3-3a2f-e053-2991aa0a015e2024-06-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.5bab9397-b9f3-d309-e053-2991aa0a66122024-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINLeading Pharma, LLC545527e7-05c7-4dbf-ab32-b3fa463d55b02024-05-10Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack4f600112-168a-4a58-9914-7c01f71894da2024-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka57066d7-dc2c-d2d0-b003-d9143fcca1c52024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINA-S Medication Solutions6971a958-08f0-4712-bf5f-47fe4f76b8632023-11-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINAsclemed USA, Inc.86c2ba30-9372-4e70-88a2-e6e1da07fa922023-09-02Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINProficient Rx LP6b5fe0aa-c74f-42f3-a84a-1cb16009aa802023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPharmPak, Inc.e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a2022-10-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticals7049f870-6741-4a67-8033-398c36126a062022-09-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINProficient Rx LPfbcd32c0-bcfd-4cc7-8e81-6612bc0cfc452022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINProficient Rx LP05b2836d-cd3d-4d7f-970c-66ec2d7886672022-05-02Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINAsclemed USA, Inc.1bb1d26e-fad0-4338-8948-3f095d5817a62022-03-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINProficient Rx LP4af3894a-8945-4b2d-bdf6-a83bbd415b892020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINAphena Pharma Solutions - Tennessee, LLCc7bc0d20-526c-48ea-b23a-cea9eb7080ff2018-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-008CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-009CiprofloxacinCiprofloxacinBaxter Healthcare CorporationANDACurrent
36000-297CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-297CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-297CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-297CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-298CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-298CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-298CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent
36000-298CIPROFLOXACINCIPROFLOXACINBaxter Healthcare CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31321ORIG2008-03-19