Application 074454

Type
ANDA
Sponsor
COSETTE

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
0472-0825Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0472-0825Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0472-0825Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
0472-0825Albuterol SulfateAlbuterol SulfateActavis Pharma, Inc.ANDACurrent
67296-1348Albuterol SulfateAlbuterol SulfateRedPharm Drug, Inc.ANDACurrent
67296-1348Albuterol SulfateAlbuterol SulfateRedPharm Drug, Inc.ANDACurrent
68788-7390Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7390Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals Inc.ANDACurrent