FDA.reportPublic FDA data

Application 078171

Type
ANDA
Sponsor
CIPLA

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
43598-409levalbuterol inhalationlevalbuterol inhalation 1.25mg/3mLDr. ReddyANDACurrent
43598-409levalbuterol inhalationlevalbuterol inhalation 1.25mg/3mLDr. ReddyANDACurrent
43598-410levalbuterol inhalationlevalbuterol inhalation 0.63mg/3mLDr. ReddyANDACurrent
43598-410levalbuterol inhalationlevalbuterol inhalation 0.63mg/3mLDr. ReddyANDACurrent
43598-412levalbuterol inhalationlevalbuterol inhalation 0.31mg/3mLDr. ReddyANDACurrent
43598-412levalbuterol inhalationlevalbuterol inhalation 0.31mg/3mLDr. ReddyANDACurrent