ANDA 077625

ZYDUS PHARMS USA

FDA Drug Application

Application #077625

Documents

• Healthcare Professional Sheet: 2008-02-01

Application Sponsors

ANDA 077625

ZYDUS PHARMS USA

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	2006-10-16
LABELING; Labeling	SUPPL	2	AP	2010-08-11
REMS; REMS	SUPPL	3	AP	2010-08-11
REMS; REMS	SUPPL	4	AP	2011-09-27
LABELING; Labeling	SUPPL	5	AP	2012-05-30
LABELING; Labeling	SUPPL	6	AP	2012-05-30
LABELING; Labeling	SUPPL	7	AP	2020-03-12	STANDARD
LABELING; Labeling	SUPPL	8	AP	2022-05-25	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77625
            [companyName] => ZYDUS PHARMS USA
            [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
        )

)