ANDA 201892

SANDOZ INC

FDA Drug Application

Application #201892

Application Sponsors

ANDA 201892

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 0.5MG BASE	0	RASAGILINE MESYLATE	RASAGILINE MESYLATE
002	TABLET;ORAL	EQ 1MG BASE	0	RASAGILINE MESYLATE	RASAGILINE MESYLATE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2018-07-27

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201892
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 0.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RASAGILINE MESYLATE","activeIngredients":"RASAGILINE MESYLATE","strength":"EQ 1MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-08
        )

)