FDA.reportPublic FDA data

Application 077734

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 5MG BASENoNo
002ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 10MG BASENoNo
003ESCITALOPRAM OXALATEESCITALOPRAM OXALATETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-102escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-102escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-103escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-103escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-104escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-104escitalopramescitalopramZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1145escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1145escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1146escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramZydus Lifesciences LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent
70771-1147escitalopramescitalopramCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9077ORIG2011-05-10