FDA.reportPublic FDA data

Application 201450

Type
ANDA
Sponsor
HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDESOLUTION;ORALEQ 10MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0564Citalopram HydrobromideCitalopram HydrobromideATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0564Citalopram HydrobromideCitalopram HydrobromideATLANTIC BIOLOGICALS CORP.ANDACurrent
31722-564Citalopram HydrobromideCitalopram HydrobromideCamber Pharmaceuticals, Inc.ANDACurrent
31722-564Citalopram HydrobromideCitalopram HydrobromideCamber Pharmaceuticals, Inc.ANDACurrent