ANDA 040610

VISTAPHARM

FDA Drug Application

Application #040610

Application Sponsors

ANDA 040610

VISTAPHARM

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

125MG/5ML

0

PHENYTOIN

PHENYTOIN

FDA Submissions

	ORIG	1	AP	2005-08-18
LABELING; Labeling	SUPPL	3	AP	2014-01-16
LABELING; Labeling	SUPPL	4	AP	2014-01-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-01-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-07-02	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	15	Null	15
SUPPL	18	Null	7

TE Codes

001

Prescription

AB

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40610
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYTOIN","activeIngredients":"PHENYTOIN","strength":"125MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYTOIN","submission":"PHENYTOIN","actionType":"125MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)