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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINDirect_Rx36d6c27d-45dc-3081-e063-6394a90a87e92026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPreferred Pharmaceuticals, Inc.85c48ebc-d94a-4254-86df-d2c1aff09b372026-01-13Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNorthwind Health Company, LLCf6debb60-d885-230b-e053-6394a90ad73a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINNorthwind Health Company, LLCf67d727f-b9ca-aec0-e053-2995a90aab692026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINQPharma Inc4d5afeff-3917-43e1-9d12-d70ccab00dcc2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINChartwell RX, LLC905503ef-4277-44ca-aa4a-5a969a041e162025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.74e2dd24-5c6e-4dde-a2ab-f2d2e61734d82025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
Ciprofloxacin in DextroseCIPROFLOXACINProPharma Distribution42c758be-4d44-018a-e063-6294a90ae0412025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
Ciprofloxacin in DextroseCIPROFLOXACINHospira, Inc.cbbbf939-3219-4515-a48e-ca264daa4d072025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINMethod Pharmaceuticals, LLCacb03e72-ce94-58c5-e053-2a95a90a683a2025-10-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINQPharma, Inc.4149d980-a6cd-c06d-e063-6394a90a47a12025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINRising Pharma Holdings, Inc.ef468722-68cd-440b-afd7-2285029db41f2025-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.2491e6a9-3415-43b9-b31b-67331f52806a2025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.e81341c6-0e25-4860-adda-2d3cebe88d622025-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.178dc379-e2b8-4b47-9f0c-3fc7fb435c362025-06-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINA-S Medication Solutionsc12b316f-811c-48b6-a320-d314991aa74f2025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINBryant Ranch Prepack69df48cc-76b6-428e-891a-c25e07d785f82025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINBryant Ranch Prepacka5ecc693-b8fd-4a7a-8040-e56f801c93532025-03-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINAdvanced Rx of Tennessee, LLC30cb2b42-aa4b-8cec-e063-6394a90aa6152025-03-20Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINCoupler LLC2fff7a38-2c4e-d343-e063-6294a90aca3c2025-03-10Boxed 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