FDA.reportPublic FDA data

Application 076155

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESPRAY, METERED;NASAL0.042MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-527Ipratropium Bromideipratropium bromideNORTHSTAR RX LLCANDACurrent
50090-5968Ipratropium Bromideipratropium bromideA-S Medication SolutionsANDACurrent
60505-0827Ipratropium Bromideipratropium bromideApotex Corp.ANDACurrent
60505-0827Ipratropium Bromideipratropium bromideApotex Corp.ANDACurrent