FDA.reportPublic FDA data

Application 072894

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoYes
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0255Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0255Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0255Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0255Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0572Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0572Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0572Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0572Albuterolalbuterol sulfateMylan Pharmaceuticals Inc.ANDACurrent
51079-657AlbuterolalbuterolMylan Institutional Inc.ANDACurrent
51079-657AlbuterolAlbuterolMylan Institutional Inc.ANDACurrent
51079-657AlbuterolAlbuterolMylan Institutional Inc.ANDACurrent
51079-658AlbuterolalbuterolMylan Institutional Inc.ANDACurrent
55289-045Albuterolalbuterol sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-045Albuterolalbuterol sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-045Albuterolalbuterol sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-045Albuterolalbuterol sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-045Albuterolalbuterol sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent