ANDA 077641

ANI PHARMS INC

FDA Drug Application

Application #077641

Documents

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

Application Sponsors

ANDA 077641

ANI PHARMS INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 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	2007-06-14
LABELING; Labeling	SUPPL	3	AP	2007-12-12
LABELING; Labeling	SUPPL	4	AP	2019-10-25	STANDARD

Submissions Property Types

SUPPL

4

Null

7

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77641
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","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":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"100MG","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":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)