ANDA 091037

SUN PHARM INDS LTD

FDA Drug Application

Application #091037

Application Sponsors

ANDA 091037

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	2013-02-22
LABELING; Labeling	SUPPL	2	AP	2014-12-15	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91037
            [companyName] => SUN PHARM INDS LTD
            [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
        )

)