ANDA 040540

ATHENEX INC

FDA Drug Application

Application #040540

Application Sponsors

ANDA 040540

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE EDISYLATE

FDA Submissions

	ORIG	1	AP	2004-05-28
LABELING; Labeling	SUPPL	3	AP	2007-09-25
LABELING; Labeling	SUPPL	5	AP	2008-09-03
LABELING; Labeling	SUPPL	7	AP	2009-03-12
LABELING; Labeling	SUPPL	8	AP	2009-08-17
LABELING; Labeling	SUPPL	9	AP	2010-12-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2019-03-11

Submissions Property Types

ORIG	1	Null	1
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	16	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40540
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCHLORPERAZINE EDISYLATE","activeIngredients":"PROCHLORPERAZINE EDISYLATE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROCHLORPERAZINE EDISYLATE","submission":"PROCHLORPERAZINE EDISYLATE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)