FDA.reportPublic FDA data

Application 021918

Type
NDA
Sponsor
WRASER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETRAXALCIPROFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OTICEQ 0.2% BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021918-001CETRAXALCIPROFLOXACIN HYDROCHLORIDEEQ 0.2% BASESOLUTION/DROPS / OTICABRLD, RS2009-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021918-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021918-001CETRAXALEQ 0.2% BASESOLUTION/DROPS / OTICABRLD, RS2009-05-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021918-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.14c3bc33-201d-492e-9aee-a4d84c813a3d2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEHAWAII REPACK, INC.0fe3becb-f90e-4187-a8e8-bd0de5a79ad22026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a2ffa81a-86c5-40b9-8fa0-c889801ef4792026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a914512b-9a4a-4c53-ab7a-2e2b1ea8a0122026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPb281a5c0-5f3e-4e6f-86ac-ed7794aac64c2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.47d1e4c5-f669-4aca-9e8c-0d6bb833b8592026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited6a935846-3c97-4517-bc4e-2377f673285e2026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDERedpharm Drug1ac4540c-d0f7-70bc-e063-6394a90a0f7a2026-05-05Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions4dd69fb7-802a-4278-a730-c722a3ca35212026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionsd8b21832-b74f-4f85-a304-b907c9e01e722026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions9d83b127-ef13-4b2c-aa30-0f54937dc2402026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging275de35b-5c97-4ff8-a571-42e23c1cd83e2026-05-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.ae77a5c0-a2ae-770c-e053-2a95a90a6a962026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs26e2d370-f59c-40ae-9c1e-7f8bf1f9fde42026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAmerican Health Packaging0fac4466-fbe5-49d2-96e3-e3ac2739bd5b2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.78641acd-eedf-4b68-bb18-da0874415f592026-03-27Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACINCIPROFLOXACIN HYDROCHLORIDEDIRECT RXa7e5174a-dd01-6050-e053-2a95a90add3f2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
CiproCIPROFLOXACIN HYDROCHLORIDEBayer HealthCare Pharmaceuticals Inc.888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c02026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDERedpharm Drug4972e902-e042-e947-e063-6394a90a1b702026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1057be77-00bb-4839-be3d-c8e11ae531a22026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CIPROFLOXACIN HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42195-550Ciprofloxacin OticCIPROFLOXACINXspire Pharma, LlcNDACurrent
42195-550Ciprofloxacin OticCIPROFLOXACINXspire PharmaNDACurrent
42195-550Ciprofloxacin OticCIPROFLOXACINXspire PharmaNDACurrent
66992-450CETRAXALCiprofloxacinWraser LlcNDACurrent
66992-450CETRAXALCiprofloxacinWraser LlcNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24228ORIG2009-10-06
21870ORIG2009-10-06
37873ORIG2009-05-11
28841ORIG2009-05-06
64788ORIG1900-01-01
53212ORIG1900-01-01
53211ORIG1900-01-01
53210ORIG1900-01-01