FDA.reportPublic FDA data

Application 201971

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RASAGILINE MESYLATERASAGILINE MESYLATETABLET;ORALEQ 0.5MG BASENoNo
002RASAGILINE MESYLATERASAGILINE MESYLATETABLET;ORALEQ 1MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1270Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1270Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1270Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1270Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1270Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1271Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1271Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1271Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1271Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-1271Rasagiline Mesylaterasagiline mesylateMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48402ORIG2017-05-17
48394ORIG2017-05-17