ANDA 077644

UPSHER SMITH LABS

FDA Drug Application

Application #077644

Documents

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

Application Sponsors

ANDA 077644

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2005-12-22
LABELING; Labeling	SUPPL	3	AP	2012-05-29
LABELING; Labeling	SUPPL	4	AP	2012-05-29
LABELING; Labeling	SUPPL	6	AP	2016-07-18	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77644
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)