FDA.reportPublic FDA data

Application 081048

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53489-330Imipramine HydrochlorideImipramine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
54738-912Imipramine HydrochlorideImipramine HydrochlorideRichmond Pharmaceuticals, Inc.ANDACurrent