ANDA 040342

VISTAPHARM

FDA Drug Application

Application #040342

Documents

• Letter: 2001-01-31

Application Sponsors

ANDA 040342

VISTAPHARM

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SUSPENSION;ORAL	125MG/5ML	0	PHENYTOIN	PHENYTOIN
002	SUSPENSION;ORAL	125MG/5ML	0	PHENYTOIN	PHENYTOIN

FDA Submissions

	ORIG	1	AP	2001-01-31
LABELING; Labeling	SUPPL	5	AP	2010-01-26
LABELING; Labeling	SUPPL	6	AP	2014-01-15
LABELING; Labeling	SUPPL	8	AP	2014-01-15	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-01-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	15	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	20	AP	2021-07-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	2021-07-02	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	15	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40342
            [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
        )

)