FDA.reportPublic FDA data

Application 078766

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9807EscitalopramEscitalopramWest-Ward Pharmaceuticals CorpANDACurrent
0143-9808EscitalopramEscitalopramWest-Ward Pharmaceuticals CorpANDACurrent
0143-9809EscitalopramEscitalopramWest-Ward Pharmaceuticals CorpANDACurrent
43063-389EscitalopramEscitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-390EscitalopramEscitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
59115-100EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
59115-100EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
59115-101EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
59115-101EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
59115-102EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
59115-102EscitalopramEscitalopramHikma PharmaceuticalANDACurrent
68258-7128EscitalopramEscitalopramDispensing Solutions, Inc.ANDACurrent