Application 211888

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
59651-183ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-183ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-183ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-183ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-184ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-184ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-184ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent
59651-184ALBUTEROL SULFATEALBUTEROL SULFATEAurobindo Pharma LimitedANDACurrent