FDA.reportPublic FDA data

Application 078202

Type
ANDA
Sponsor
NEPHRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.25MG/2MLNoNo
002BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.5MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0487-9601BudesonideBUDESONIDENephron SC Inc.ANDACurrent
0487-9601BudesonideBUDESONIDENephron SC Inc.ANDACurrent
0487-9601BudesonideBUDESONIDENephron Pharmaceuticals CorporationANDACurrent
0487-9701BudesonideBUDESONIDENephron SC Inc.ANDACurrent
0487-9701BudesonideBUDESONIDENephron SC Inc.ANDACurrent
0487-9701BudesonideBUDESONIDENephron Pharmaceuticals CorporationANDACurrent
60505-0820BudesonideBudesonideApotex Corp.ANDACurrent
60505-0820BUDESONIDEBUDESONIDEApotex Corp.ANDACurrent
60505-0821BudesonideBudesonideApotex Corp.ANDACurrent
60505-0821BUDESONIDEBUDESONIDEApotex Corp.ANDACurrent
68788-6873BudesonideBUDESONIDEPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43135ORIG2011-12-02