FDA.reportPublic FDA data

Application 021641

Type
NDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZILECTRASAGILINE MESYLATETABLET;ORALEQ 0.5MG BASEYesNo
002AZILECTRASAGILINE MESYLATETABLET;ORALEQ 1MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3060RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3061RasagilineRasagilineTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
42291-779RasagilineRasagilineAvKARENDA AUTHORIZED GENERICCurrent
42291-779RasagilineRasagilineAvKARENDA AUTHORIZED GENERICCurrent
42291-780RasagilineRasagilineAvKARENDA AUTHORIZED GENERICCurrent
42291-780RasagilineRasagilineAvKARENDA AUTHORIZED GENERICCurrent
43353-015AzilectRasagiline MesylateAphena Pharma Solutions - Tennessee, LLCNDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-142AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent
68546-229AzilectRasagiline mesylateTeva Neuroscience, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63599SUPPL2020-06-17
63593SUPPL2020-06-17
56979SUPPL2018-12-21
5904SUPPL2014-06-02
5903SUPPL2014-06-02
37386SUPPL2014-05-30
15913SUPPL2014-05-30
28298SUPPL2010-01-26
28297SUPPL2010-01-26
28296SUPPL2010-01-26
28295SUPPL2010-01-26
28294SUPPL2010-01-26
5902SUPPL2010-01-26
5901SUPPL2010-01-26
42246SUPPL2010-01-22
24207SUPPL2010-01-22
37385SUPPL2009-12-10
37384SUPPL2009-12-10
37383SUPPL2009-12-10
37382SUPPL2009-12-10
15912SUPPL2009-12-10
15911SUPPL2009-12-10
15910SUPPL2009-12-10
21765ORIG2006-07-24
5900ORIG2006-05-21
37381ORIG2006-05-18