Application 077654

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 10MG BASENoNo
002CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 20MG BASENoNo
003CITALOPRAM HYDROBROMIDECITALOPRAM HYDROBROMIDETABLET;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-113Citalopram HydrobromideCitalopram HydrobromideGlenmark Generics Inc., USAANDACurrent
68462-114Citalopram HydrobromideCitalopram HydrobromideGlenmark Generics Inc., USAANDACurrent
68462-115Citalopram HydrobromideCitalopram HydrobromideGlenmark Generics Inc., USAANDACurrent
72657-109Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent
72657-109Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent
72657-110Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent
72657-110Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent
72657-111Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent
72657-111Citalopram HydrobromideCitalopram HydrobromideGlenmark Therapeutics Inc., USAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23880ORIG2009-03-19