FDA.reportPublic FDA data

Application 215620

Type
ANDA
Sponsor
INDOCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETYLCYSTEINEACETYLCYSTEINEINJECTABLE;INTRAVENOUS6GM/30ML (200MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
14445-412ACETYLCYSTEINEACETYLCYSTEINEIndoco Remedies LimitedANDACurrent
72611-860ACETYLCYSTEINEACETYLCYSTEINEAlmaject, Inc.ANDACurrent