FDA.reportPublic FDA data

Application 077519

Type
ANDA
Sponsor
TEVA PHARMS

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
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6815BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-6816BudesonideBudesonideTeva Pharmaceuticals USA, Inc.ANDACurrent
55154-4849BudesonideBudesonideCardinal HealthANDACurrent
55154-4849BudesonideBudesonideCardinal Health 107, LLCANDACurrent
55154-4849BudesonideBudesonideCardinal HealthANDACurrent
68258-8922BudesonideBudesonideDispensing Solutions, Inc.ANDACurrent
68788-0012BudesonideBudesonidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0013BudesonideBudesonidePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31255ORIG2008-11-21