Application 077044

Type
ANDA
Sponsor
CHARTWELL MOLECULAR

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
67046-116Citalopram HydrobromideCitalopram HydrobromideContract Pharmacy Services-PAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23854ORIG2005-07-29