FDA.reportPublic FDA data

Application 078032

Type
ANDA
Sponsor
PRINSTON INC

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
42708-155EscitalopramEscitalopramQPharma IncANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-280EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-281EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
43547-282EscitalopramEscitalopramSOLCO HEALTHCARE US, LLCANDACurrent
50090-5312EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
50090-6190EscitalopramEscitalopramA-S Medication SolutionsANDACurrent
51655-284EscitalopramEscitalopramNorthwind PharmaceuticalsANDACurrent
51655-284EscitalopramEscitalopramNorthwind PharmaceuticalsANDACurrent
53002-2438EscitalopramEscitalopramRPK Pharmaceuticals, Inc.ANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-818EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
55700-847EscitalopramEscitalopramQuality Care Products, LLCANDACurrent
60760-393EscitalopramEscitalopramSt. Mary's Medical Park PharmacyANDACurrent
63629-8241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
67046-355EscitalopramEscitalopramContract Pharmacy Services-PAANDACurrent
67296-1408EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1421EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1597EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
67296-1597EscitalopramEscitalopramRedPharm Drug, Inc.ANDACurrent
68071-4984EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4984EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5248EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5248EscitalopramEscitalopramNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7461EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7510EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7559EscitalopramEscitalopramPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2317EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2430EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2472EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70518-2597EscitalopramEscitalopramREMEDYREPACK INC.ANDACurrent
70934-630EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-646EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-650EscitalopramEscitalopramDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1187EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1241EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1307EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1307EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1445EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1445EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent
71335-1571EscitalopramEscitalopramBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31323ORIG2011-05-10
44370ORIG2007-01-18