FDA.reportPublic FDA data

Application 019857

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACININJECTABLE;INJECTION400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26
N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERCIPROFLOXACIN400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26c2088c7a36db…
2026-10-15 13:18:302026-09N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26c2088c7a36db…
2026-09-14 22:38:342026-08N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2684e616aacf4f…
2026-08-18 06:07:402026-07N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONRLD1990-12-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONRLD1990-12-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019857-001CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100MLINJECTABLE / INJECTIONRLD1990-12-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019857-002CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200MLINJECTABLE / INJECTIONRLD1990-12-264b0b4de00fa7…

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 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-759CiprociprofloxacinBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70612SUPPL2022-03-28
70611SUPPL2022-03-28
62892SUPPL2020-05-11
62891SUPPL2020-05-11
62888SUPPL2020-05-11
62092SUPPL2020-03-10
62091SUPPL2020-03-10
58609SUPPL2019-05-07
58605SUPPL2019-05-07
56064SUPPL2018-10-23
56037SUPPL2018-10-19
49425SUPPL2017-08-16
49424SUPPL2017-08-16
49107SUPPL2017-07-28
19777SUPPL2016-07-26
11795SUPPL2016-07-26
34052SUPPL2015-03-20
19776SUPPL2015-03-20
34051SUPPL2015-03-02
1729SUPPL2015-02-12
19775SUPPL2013-08-16
11794SUPPL2013-08-15
34050SUPPL2013-02-01
1728SUPPL2013-01-31
19771SUPPL2011-11-21
34048SUPPL2011-11-16
11793SUPPL2011-11-04
19774SUPPL2011-10-20
11792SUPPL2011-08-16
19773SUPPL2011-08-15
34049SUPPL2011-08-12
1727SUPPL2011-08-08
11791SUPPL2011-03-04
19772SUPPL2011-03-02
1726SUPPL2009-06-30
34047SUPPL2009-05-11
1725SUPPL2009-05-07
11790SUPPL2009-02-20
1724SUPPL2009-02-18
34046SUPPL2008-10-09
41063SUPPL2008-08-11
20399SUPPL2008-08-04
41068SUPPL2008-07-31
41067SUPPL2008-07-31
41066SUPPL2008-07-31
41065SUPPL2008-07-31
19770SUPPL2008-01-24
34045SUPPL2008-01-23
41069SUPPL2007-07-09
19769SUPPL2007-07-05
11789SUPPL2007-06-27
1723SUPPL2006-06-28
19768SUPPL2005-11-18
34044SUPPL2005-11-17
34043SUPPL2005-05-20
1722SUPPL2005-05-20
34042SUPPL2005-01-11
1720SUPPL2005-01-11
34041SUPPL2004-07-21
19767SUPPL2004-07-21
11788SUPPL2004-07-21
11787SUPPL2004-07-21
1721SUPPL2004-07-21
1719SUPPL2004-07-21
11786SUPPL2004-04-05
1718SUPPL2004-03-28
34040SUPPL2002-04-17
1717SUPPL2002-04-17
41064SUPPL2000-08-30
19766SUPPL2000-08-30
11785SUPPL2000-08-30