FDA.reportPublic FDA data

Application 075664

Type
ANDA
Sponsor
NEPHRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.5% BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0487-9901Albuterol SulfateAlbuterol SulfateNephron SC Inc.ANDACurrent
0487-9901Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent
55154-4350Albuterol SulfateAlbuterol SulfateCardinal Health, Inc.ANDACurrent
55154-4350Albuterol SulfateAlbuterol SulfateCardinal Health 107, LLCANDACurrent
55154-4350Albuterol SulfateAlbuterol SulfateCardinal Health, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43018ORIG2005-07-22
8754ORIG2003-04-14