ANDA 073229

CATALENT

FDA Drug Application

Application #073229

Application Sponsors

ANDA 073229

CATALENT

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	1991-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-11-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-01-27
LABELING; Labeling	SUPPL	6	AP	2001-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-06-29
LABELING; Labeling	SUPPL	11	AP	2014-08-05
LABELING; Labeling	SUPPL	12	AP	2015-12-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-12-26	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CATALENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73229
            [companyName] => CATALENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)