ANDA 077526

CELLTRION

FDA Drug Application

Application #077526

Application Sponsors

ANDA 077526

CELLTRION

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE
002	TABLET;ORAL	EQ 10MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE

FDA Submissions

	ORIG	1	AP	2013-03-26
LABELING; Labeling	SUPPL	2	AP	2020-01-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77526
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"RIZATRIPTAN BENZOATE","submission":"RIZATRIPTAN BENZOATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"RIZATRIPTAN BENZOATE","submission":"RIZATRIPTAN BENZOATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)