FDA.reportPublic FDA data

Application 077788

Type
ANDA
Sponsor
VISTAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESYRUP;ORALEQ 2MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-189ALBUTEROL SULFATEAlbuterol SulfateChartwell RX, LLCANDACurrent
62135-189ALBUTEROL SULFATEAlbuterol SulfateChartwell RX, LLCANDACurrent
66689-100Albuterol SulfateAlbuterolVistaPharm, Inc.ANDACurrent