FDA.reportPublic FDA data

Application 074979

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONAZEPAMCLONAZEPAMTABLET;ORAL0.5MGNoNo
002CLONAZEPAMCLONAZEPAMTABLET;ORAL1MGNoNo
003CLONAZEPAMCLONAZEPAMTABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0063ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0063ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0064ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0064ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0065ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0065ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0781-5567ClonazepamClonazepamSandoz IncANDACurrent
0781-5567ClonazepamClonazepamSandoz IncANDACurrent
0781-5569ClonazepamClonazepamSandoz IncANDACurrent
0781-5569ClonazepamClonazepamSandoz IncANDACurrent
0781-8018ClonazepamClonazepamSandoz IncANDACurrent
0781-8018ClonazepamClonazepamSandoz IncANDACurrent
0904-6101ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
0904-6102ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
0904-6103ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
16714-469ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-469ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-470ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-470ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-471ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-471ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-750ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-750ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-751ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-751ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-752ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-752ClonazepamClonazepamNorthstar RxLLCANDACurrent
50090-1565ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-2878ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-2878ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-3467ClonazepamClonazepamA-S Medication SolutionsANDACurrent
53217-189ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
53217-247ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
53217-326ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
70518-0154ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-0259ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-0259ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1069ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1069ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1199ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1199ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
71335-0001ClonazepamClonazepamBryant Ranch PrepackANDACurrent
71335-0001ClonazepamClonazepamBryant Ranch PrepackANDACurrent
71335-1060ClonazepamClonazepamBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22398ORIG2011-03-10