Application 020463

Type
NDA
Sponsor
BLACKSMITH BRANDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NASALCROMCROMOLYN SODIUMSPRAY, METERED;NASAL5.2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020463-001NASALCROMCROMOLYN SODIUM5.2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD1997-01-03

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NasalCromCROMOLYN SODIUMPrestige Brands Holdings, Inc.b34d36ca-4df4-458c-af0f-c0d0c9a025d92026-06-03WarningsName fallback

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use if you are allergic to any of the ingredients Ask a doctor before use if you have fever discolored nasal discharge sinus pain wheezing When using this product it may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks. brief stinging or sneezing may occur right after use do not use it to treat sinus infection, asthma, or cold symptoms do not share this bottle with anyone else as this may spread germs Stop use and ask a doctor if shortness of breath, wheezing, or chest tightness occurs hives or swelling of the mouth or throat occurs your symptoms worsen you have new symptoms your symptoms do not begin to improve within two weeks you need to use for more than 12 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24999SUPPL2004-07-21
20668SUPPL2001-03-27
2566SUPPL2001-03-27