FDA.reportPublic FDA data

Application 207820

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.0103% BASENoNo
002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.021% BASENoNo
003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDESOLUTION;INHALATIONEQ 0.042% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-094Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionNorthStar RxLLCANDACurrent
16714-095Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionNorthStar RxLLCANDACurrent
16714-096Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionNorthStar RxLLCANDACurrent
47335-743Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-743Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-743Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-746Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-746Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-746Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-753Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-753Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
47335-753Levalbuterol Inhalation SolutionLevalbuterol Inhalation SolutionSun Pharmaceutical Industries, Inc.ANDACurrent
68071-2340LevalbuterolLevalbuterolNuCare Pharmaceuticals,Inc.ANDACurrent