FDA.reportPublic FDA data

Application 214531

Type
ANDA
Sponsor
RITEDOSE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.021% BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.042% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7057Albuterol SulfateAlbuterol SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-7057Albuterol SulfateAlbuterol SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-7058Albuterol SulfateAlbuterol SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-7058Albuterol SulfateAlbuterol SulfateMylan Pharmaceuticals Inc.ANDACurrent
65302-060Albuterol Sulfate Inhalation SolutionAlbuterol SulfateThe Ritedose CorporationANDACurrent
65302-061Albuterol Sulfate Inhalation SolutionAlbuterol SulfateThe Ritedose CorporationANDACurrent
65302-064Albuterol Sulfate Inhalation SolutionAlbuterol SulfateThe Ritedose CorporationANDACurrent
65302-065Albuterol Sulfate Inhalation SolutionAlbuterol SulfateThe Ritedose CorporationANDACurrent
76204-010Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent
76204-010Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent
76204-010Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent
76204-011Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent
76204-011Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent
76204-011Albuterol Sulfate Inhalation SolutionAlbuterol SulfateRitedose Pharmaceuticals, LLCANDACurrent