ANDA 206153

INDOCO REMEDIES

FDA Drug Application

Application #206153

Application Sponsors

ANDA 206153

INDOCO REMEDIES

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

UNKNOWN;	ORIG	1	AP	2019-10-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-01-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INDOCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206153
            [companyName] => INDOCO
            [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":"10\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-04
        )

)