FDA.reportPublic FDA data

Application 076765

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-5850EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5850EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5850EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5850EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5851EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5851EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5851EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5851EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5852EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5852EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5852EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5852EscitalopramEscitalopramTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7720EscitalopramEscitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7721EscitalopramEscitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7722EscitalopramEscitalopramNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-725EscitalopramEscitalopramRebel Distributors CorpANDACurrent
33261-954EscitalopramEscitalopramAidarex Pharmaceuticals LLCANDACurrent
42254-362EscitalopramEscitalopramRebel Distributors CorpANDACurrent
42708-022EscitalopramEscitalopramQPharma IncANDACurrent
42708-022EscitalopramEscitalopramQPharma IncANDACurrent
42708-022EscitalopramEscitalopramQPharma IncANDACurrent
42708-023EscitalopramEscitalopramQPharma IncANDACurrent
42708-023EscitalopramEscitalopramQPharma IncANDACurrent
42708-023EscitalopramEscitalopramQPharma IncANDACurrent
43063-521EscitalopramEscitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-521EscitalopramEscitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-521EscitalopramEscitalopramPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-787EscitalopramEscitaloprammedsource pharmaceuticalsANDACurrent
50090-3331EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
50090-3331EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
50090-3360EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
51655-021ESCITALOPRAMescitalopram oxalateNorthwind Pharmaceuticals, LLCANDACurrent
51655-151EscitalopramEscitalopramNorthwind PharmaceuticalsANDACurrent
54458-891EscitalopramEscitalopramInternational Laboratories, LLCANDACurrent
54458-891EscitalopramEscitalopramInternational Laboratories, LLCANDACurrent
54458-892EscitalopramEscitalopramInternational Laboratories, LLCANDACurrent
54458-892EscitalopramEscitalopramInternational Laboratories, LLCANDACurrent
55700-013EscitalopramEscitalopramLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-157EscitalopramEscitalopramLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-217EscitalopramEscitalopramProficient Rx LPANDACurrent
63187-217EscitalopramEscitalopramProficient Rx LPANDACurrent
63187-281EscitalopramEscitalopramProficient Rx LPANDACurrent
63187-281EscitalopramEscitalopramProficient Rx LPANDACurrent
63629-4688EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
63629-4688EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
63629-4699EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
63629-5349EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
64205-585EscitalopramEscitalopramReadyMedsANDACurrent
67046-171EscitalopramEscitalopramContract Pharmacy Services-PAANDACurrent
67296-1528EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1528EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1731EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
68071-2051EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2051EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4332EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6403EscitalopramEscitalopramPreferred Pharmaceuticals Inc.ANDACurrent
68788-9302EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0692EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-0692EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8958ORIG2012-03-16
31162ORIG2011-05-10
23835ORIG2006-06-06
8957ORIG2006-05-25