FDA.reportPublic FDA data

Application 205710

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.25MG/2MLNoNo
002BUDESONIDEBUDESONIDESUSPENSION;INHALATION0.5MG/2MLNoNo
003BUDESONIDEBUDESONIDESUSPENSION;INHALATION1MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-018BudesonideBudesonideNorthStar RxLLCANDACurrent
16714-019BudesonideBudesonideNorthStar RxLLCANDACurrent
16714-020BudesonideBudesonideNorthStar RxLLCANDACurrent
60687-645BudesonideBudesonideAmerican Health PackagingANDACurrent
68788-7290BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7290BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7290BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7290BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7314BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7314BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7314BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7314BudesonideBudesonidePreferred Pharmaceuticals Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-318BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-319BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
69097-321BudesonideBudesonideCipla USA Inc.ANDACurrent
76282-640BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-640BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-640BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-640BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-641BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-641BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-641BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-641BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-642BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-642BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-642BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent
76282-642BudesonideBudesonideExelan Pharmaceuticals, Inc.ANDACurrent