ANDA 077869

INVAGEN PHARMS

FDA Drug Application

Application #077869

Documents

• Healthcare Professional Sheet: 2008-02-01

Application Sponsors

ANDA 077869

INVAGEN PHARMS

Marketing Status

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

Application Products

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

FDA Submissions

	ORIG	1	AP	2006-05-31
LABELING; Labeling	SUPPL	2	AP	2012-06-07
LABELING; Labeling	SUPPL	3	AP	2015-06-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-02-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-03-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-05-25	STANDARD

Submissions Property Types

SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	7	Null	7
SUPPL	9	Null	7
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77869
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","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":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"25MG","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":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)