Application 077043

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0062CitalopramCitalopramWest-Ward Pharmaceuticals CorpANDACurrent
0054-0062CitalopramCitalopramHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0062CitalopramCitalopramHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18455SUPPL2014-09-05
23853ORIG2005-07-29
31190ORIG2004-12-13