FDA.reportPublic FDA data

Application 077772

Type
ANDA
Sponsor
WATSON LABS

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
0591-3467Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0591-3467Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0591-3468Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0591-3468Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent