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Application 077048

Type
ANDA
Sponsor
ACP NIMBLE

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
0615-6510CitalopramCitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6511CitalopramCitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6512CitalopramCitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0713-4740CitalopramCitalopram TabletsCosette Pharmaceuticals, Inc.ANDACurrent
0713-4740CitalopramCitalopram TabletsCosette Pharmaceuticals, Inc.ANDACurrent
0713-4740CitalopramCitalopram TabletsG&W Laboratories, Inc.ANDACurrent
0713-4740CitalopramCitalopram TabletsCosette Pharmaceuticals, Inc.ANDACurrent
0713-4741CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
0713-4741CitalopramCitalopram TabletG&W Laboratories, Inc.ANDACurrent
0713-4741CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
0713-4741CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
0713-4742CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
0713-4742CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
0713-4742CitalopramCitalopram TabletG&W Laboratories, Inc.ANDACurrent
0713-4742CitalopramCitalopram TabletCosette Pharmaceuticals, Inc.ANDACurrent
10544-149CitalopramCitalopramBlenheim Pharmacal, Inc.ANDACurrent
10544-150CitalopramCitalopramBlenheim Pharmacal, Inc.ANDACurrent
53808-0976CitalopramCitalopramState of Florida DOH Central PharmacyANDACurrent
66116-329CitalopramCitalopramMedVantx, Inc.ANDACurrent
66116-445CitalopramCitalopramMedVantx, Inc.ANDACurrent
66116-455CitalopramCitalopramMedVantx, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44336ORIG2005-07-29