ANDA 076295

ATHENEX INC

FDA Drug Application

Application #076295

Documents

• Other Important Information from FDA: 2008-02-01

Application Sponsors

ANDA 076295

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/ML

0

VALPROATE SODIUM

VALPROATE SODIUM

FDA Submissions

	ORIG	1	AP	2002-11-14
LABELING; Labeling	SUPPL	4	AP	2007-10-24

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76295
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROATE SODIUM","activeIngredients":"VALPROATE SODIUM","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROATE SODIUM","submission":"VALPROATE SODIUM","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)