FDA.reportPublic FDA data

Application 201970

Type
ANDA
Sponsor
ORCHID HLTHCARE

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
47781-138Rasagiline MesylateRasagiline MesylateAlvogen, Inc.ANDACurrent
47781-138Rasagiline MesylateRasagiline MesylateAlvogen, Inc.ANDACurrent
47781-139Rasagiline MesylateRasagiline MesylateAlvogen, Inc.ANDACurrent
47781-139Rasagiline MesylateRasagiline MesylateAlvogen, Inc.ANDACurrent
47781-683RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-683RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-683RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-683RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-690RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-690RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-690RasagilineRasagilineAlvogen, Inc.ANDACurrent
47781-690RasagilineRasagilineAlvogen, Inc.ANDACurrent