Application Nr Approved Date Route Status External Links
ANDA076103 2003-03-31 Nasal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Ipratropium Bromide Nasal Solution 0.06% (nasal Spray) Is Indicated For The Symptomatic Relief Of Rhinorrhea Associated With The Common Cold Or Seasonal Allergic Rhinitis For Adults And Children Age 5 Years And Older. Ipratropium Bromide Nasal Solution 0.06% (nasal Spray) Does Not Relieve Nasal Congestion Or Sneezing Associated With The Common Cold Or Seasonal Allergic Rhinitis. The Safety And Effectiveness Of The Use Of Ipratropium Bromide Nasal Solution 0.06% (nasal Spray) Beyond Four Days In Patients With The Common Cold Or Beyond Three Weeks In Patients With Seasonal Allergic Rhinitis Has Not Been Established.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Edetate Disodium EDETATE DISODIUM Molecular
2. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ipratropium Bromide IPRATROPIUM BROMIDE ZINC100015775

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