FDA.reportPublic FDA data

Application 075150

Type
ANDA
Sponsor
MYLAN

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
0378-1910ClonazepamclonazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-1910ClonazepamclonazepamMylan Pharmaceuticals IncANDACurrent
0378-1912ClonazepamclonazepamMylan Pharmaceuticals IncANDACurrent
0378-1912ClonazepamclonazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-1914ClonazepamclonazepamMylan Pharmaceuticals IncANDACurrent
0378-1914ClonazepamclonazepamMylan Pharmaceuticals Inc.ANDACurrent
50090-2965ClonazepamclonazepamA-S Medication SolutionsANDACurrent
50090-3375ClonazepamclonazepamA-S Medication SolutionsANDACurrent
50090-3375ClonazepamclonazepamA-S Medication SolutionsANDACurrent
51079-882ClonazepamclonazepamMylan Institutional Inc.ANDACurrent
51079-883ClonazepamclonazepamMylan Institutional Inc.ANDACurrent
55154-5452ClonazepamclonazepamCardinal HealthANDACurrent
55154-5452ClonazepamclonazepamCardinal HealthANDACurrent
55154-5462ClonazepamclonazepamCardinal HealthANDACurrent
55154-5462ClonazepamclonazepamCardinal HealthANDACurrent
55154-5462ClonazepamclonazepamCardinal HealthANDACurrent
70518-0644ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-0644ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30774ORIG1998-10-05
22433ORIG1998-10-05