FDA.reportPublic FDA data

Application 210897

Type
ANDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.5MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-524Budesonide InhalationBudesonide InhalationAmerican Health PackagingANDACurrent
60687-524Budesonide InhalationBudesonide InhalationAmerican Health PackagingANDACurrent
60687-524Budesonide InhalationBudesonide InhalationAmerican Health PackagingANDACurrent
65302-042Budesonide InhalationBudesonide Inhalation SuspensionThe Ritedose CorporationANDACurrent
68180-984budesonide inhalationbudesonide inhalationLupin Pharmaceuticals, Inc.ANDACurrent
68180-984budesonide inhalationbudesonide inhalationLupin Pharmaceuticals, Inc.ANDACurrent
68180-984budesonide inhalationbudesonide inhalationLupin Pharmaceuticals, Inc.ANDACurrent
76204-018Budesonide Inhalation SuspensionBudesonide Inhalation SuspensionRitedose Pharmaceuticals, LLCANDACurrent
76204-018Budesonide Inhalation SuspensionBudesonide Inhalation SuspensionRitedose Pharmaceuticals, LLCANDACurrent
76204-018Budesonide Inhalation SuspensionBudesonide Inhalation SuspensionRitedose Pharmaceuticals, LLCANDACurrent