Application 213657

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59651-333AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent
59651-333AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent
59651-333AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent
59651-334AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent
59651-334AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent
59651-334AlbuterolAlbuterolAurobindo Pharma LimitedANDACurrent