FDA.reportPublic FDA data

Application 207046

Type
ANDA
Sponsor
APPCO

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
63629-2611AlbuterolalbuterolBryant Ranch PrepackANDACurrent
64980-442AlbuterolalbuterolRising Pharmaceuticals, Inc.ANDACurrent
64980-442AlbuterolalbuterolRising Pharmaceuticals, Inc.ANDACurrent
64980-443AlbuterolalbuterolRising Pharmaceuticals, Inc.ANDACurrent
64980-443AlbuterolalbuterolRising Pharmaceuticals, Inc.ANDACurrent
71205-898AlbuterolalbuterolProficient Rx LPANDACurrent
71205-898AlbuterolalbuterolProficient Rx LPANDACurrent
71205-898AlbuterolalbuterolProficient Rx LPANDACurrent
71205-899AlbuterolalbuterolProficient Rx LPANDACurrent
71205-899AlbuterolalbuterolProficient Rx LPANDACurrent
71205-899AlbuterolalbuterolProficient Rx LPANDACurrent