FDA.reportPublic FDA data

Application 020805

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO HCCIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONESUSPENSION/DROPS;OTICEQ 0.2% BASE;1%YesYes

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

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
N020805-001CIPRO HCCIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONEEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020805-001AB

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICRLD, RS1998-02-10cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020805-001CIPRO HCEQ 0.2% BASE;1%SUSPENSION/DROPS / OTICABRLD, RS1998-02-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N020805-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08N020805-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N020805-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020805-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020805-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020805-001AB1a50c72e98297…

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacin hydrochloride and hydrocortisoneCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incc0881bbe-cc95-45d4-9878-3bc8946eff262026-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsd2c40b07-dc39-46c6-8ea1-b288589a46d12025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incb26594a3-2adf-4954-8be0-5bd6f8de96712024-11-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEA-S Medication Solutionsab640d62-f470-4b50-818f-0c0a339047432023-11-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
ndc (product): 50090-6043
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 020805
application number: NDA020805
ndc (product): 76420-273

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0078-0855CIPROciprofloxacin hydrochloride and hydrocortisoneNovartis Pharmaceuticals CorporationNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-6043CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
76420-273CIPROciprofloxacin hydrochloride and hydrocortisoneAsclemed USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47686SUPPL2017-03-24
47625SUPPL2017-03-21
41714ORIG1998-02-10
13467ORIG1998-02-10
3397ORIG1998-02-10