ANDA 077636

CELLTRION

FDA Drug Application

Application #077636

Documents

• Healthcare Professional Sheet: 2008-02-01
• Letter: 2005-12-28

Application Sponsors

ANDA 077636

CELLTRION

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	100MG	0	ZONISAMIDE	ZONISAMIDE
002	CAPSULE;ORAL	50MG	0	ZONISAMIDE	ZONISAMIDE
003	CAPSULE;ORAL	25MG	0	ZONISAMIDE	ZONISAMIDE

FDA Submissions

	ORIG	1	AP	2005-12-22
LABELING; Labeling	SUPPL	2	AP	2006-07-27
REMS; REMS	SUPPL	3	AP	2010-08-13

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

CELLTRION

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77636
            [companyName] => CELLTRION
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)