FDA.report

Application 077519

Type
ANDA
Sponsor
TEVA PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.25MG/2MLNoNo
002BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.5MG/2MLNoNo

NDC Listings For This Application

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

DocumentSubmission typeDate
31255ORIG2008-11-21