FDA.reportPublic FDA data

Application 076355

Type
ANDA
Sponsor
NEPHRON

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0487-0301Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent
0487-0301Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent
0487-9904Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent
0487-9904Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent