FDA.reportPublic FDA data

Application 022124

Type
NDA
Sponsor
NYCOMED US INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMNARISCICLESONIDESPRAY; NASAL50MCGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlvescoCICLESONIDECovis Pharma US, Inc9f6112fb-78ef-43cf-8ae3-36370eb454682025-02-28Warnings, Adverse reactionsName fallback
generic name: CICLESONIDE
OmnarisCICLESONIDECovis Pharma US, Inc15fefd46-ac7e-40d0-b635-e6c3d653c6662022-11-08Warnings, Adverse reactionsName fallback
brand name: Omnaris
generic name: CICLESONIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24246ORIG2009-11-12
21942ORIG2009-11-12
16990ORIG2007-11-26
6938ORIG2007-11-26
53209ORIG1900-01-01
53208ORIG1900-01-01
53207ORIG1900-01-01