FDA.reportPublic FDA data

Application 019847

Type
NDA
Sponsor
BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPROCIPROFLOXACININJECTABLE;INJECTION400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002CIPROCIPROFLOXACININJECTABLE;INJECTION200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003CIPROCIPROFLOXACININJECTABLE;INJECTION1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019847-001CIPROCIPROFLOXACIN400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26
N019847-002CIPROCIPROFLOXACIN200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26
N019847-003CIPROCIPROFLOXACIN1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26c2088c7a36db…
2026-10-15 13:18:302026-09N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26c2088c7a36db…
2026-10-15 13:18:302026-09N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26c2088c7a36db…
2026-09-14 22:38:342026-08N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-2684e616aacf4f…
2026-08-18 06:07:402026-07N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2025-12N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2025-12N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2025-03N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2025-03N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2025-02N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2025-02N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2025-01N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2025-01N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2024-12N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2024-12N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2024-09N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2024-09N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019847-001CIPRO400MG/40ML (10MG/ML) **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 ZIP2024-11N019847-002CIPRO200MG/20ML (10MG/ML) **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 ZIP2024-11N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N019847-002CIPRO200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N019847-003CIPRO1200MG/120ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTION1990-12-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019847-001CIPRO400MG/40ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-12-2679d66fd596c7…

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 · 75 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
CiprofloxacinCIPROFLOXACINSagent Pharmaceuticalsf406e796-17d9-4465-b8a7-00d966a4ba742026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN
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
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
brand name: Cipro
generic name: CIPROFLOXACIN
ciprofloxacinCIPROFLOXACINSportpharm LLC190395a8-c05f-4e31-9a89-7af6428ebbb92026-02-05Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79940SUPPL 2024-10-21
79895SUPPL 2024-10-15
79893SUPPL 2024-10-15
70631SUPPL2022-03-28
70614SUPPL2022-03-28
70613SUPPL2022-03-28
62902SUPPL2020-05-11
62901SUPPL2020-05-11
62895SUPPL2020-05-11
62090SUPPL2020-03-09
62089SUPPL2020-03-09
62071SUPPL2020-03-06
58607SUPPL2019-05-07
58606SUPPL2019-05-07
58575SUPPL2019-05-06
56130SUPPL2018-10-29
56129SUPPL2018-10-29
56063SUPPL2018-10-23
49192SUPPL2017-08-02
49162SUPPL2017-07-31
34028SUPPL2016-07-26
1705SUPPL2016-07-26
11777SUPPL2015-03-20
1704SUPPL2015-03-20
11776SUPPL2015-03-02
1703SUPPL2015-02-12
19753SUPPL2013-08-16
34027SUPPL2013-08-15
34026SUPPL2013-02-01
1702SUPPL2013-01-31
19749SUPPL2011-11-21
34025SUPPL2011-11-16
11775SUPPL2011-11-04
19752SUPPL2011-10-20
11774SUPPL2011-08-16
19751SUPPL2011-08-15
1701SUPPL2011-08-08
43629ORIG2011-03-15
11773SUPPL2011-03-04
19750SUPPL2011-03-02
1700SUPPL2009-06-30
34024SUPPL2009-05-11
1699SUPPL2009-05-07
11772SUPPL2009-02-20
1698SUPPL2009-02-18
34023SUPPL2008-10-09
1697SUPPL2008-10-07
41059SUPPL2008-08-11
20392SUPPL2008-08-08
20394SUPPL2008-08-04
41061SUPPL2008-07-31
41060SUPPL2008-07-31
20396SUPPL2008-07-31
20395SUPPL2008-07-31
19748SUPPL2008-01-24
34022SUPPL2008-01-23
20397SUPPL2007-07-09
19747SUPPL2007-07-05
34021SUPPL2007-06-27
19746SUPPL2006-06-28
1696SUPPL2005-11-18
11771SUPPL2005-11-17
34020SUPPL2005-05-20
19745SUPPL2005-05-20
11770SUPPL2005-01-11
1695SUPPL2005-01-11
34019SUPPL2004-07-21
34018SUPPL2004-07-21
19744SUPPL2004-07-21
19743SUPPL2004-07-21
11769SUPPL2004-07-21
1694SUPPL2004-07-21
11768SUPPL2004-04-05
1693SUPPL2004-03-28
34017SUPPL2002-04-17
1692SUPPL2002-04-17
34016SUPPL2000-08-30
20393SUPPL2000-08-30
1691SUPPL2000-08-30