FDA.reportPublic FDA data

Application 209954

Type
ANDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INHNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5231Albuterol sulfateAlbuterol sulfateA-S Medication SolutionsANDACurrent
50090-5231Albuterol sulfateAlbuterol sulfateA-S Medication SolutionsANDACurrent
53002-1554Albuterol sulfateAlbuterol sulfateRPK Pharmaceuticals, Inc.ANDACurrent
68071-2300Albuterol sulfateAlbuterol sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2300Albuterol sulfateAlbuterol sulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68180-963Albuterol sulfateAlbuterol sulfateLupin Pharmaceuticals, Inc.ANDACurrent
68180-963Albuterol sulfateAlbuterol sulfateLupin Pharmaceuticals, Inc.ANDACurrent
68180-963Albuterol sulfateAlbuterol sulfateLupin Pharmaceuticals, Inc.ANDACurrent
70518-3541Albuterol sulfateAlbuterol sulfateREMEDYREPACK INC.ANDACurrent
71205-732Albuterol sulfateAlbuterol sulfateProficient Rx LPANDACurrent