FDA.reportPublic FDA data

Application 207857

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.083% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-703Albuterol Sulfatealbuterol sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
47335-703Albuterol Sulfatealbuterol sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
68071-2656Albuterol Sulfatealbuterol sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2679Albuterol Sulfatealbuterol sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3560Albuterol Sulfatealbuterol sulfateREMEDYREPACK INC.ANDACurrent
71205-641Albuterol Sulfatealbuterol sulfateProficient Rx LPANDACurrent
71205-641Albuterol Sulfatealbuterol sulfateProficient Rx LPANDACurrent