ANDA 075634

ATHENEX INC

FDA Drug Application

Application #075634

Documents

• Letter: 2000-08-22
• Letter: 2004-06-03

Application Sponsors

ANDA 075634

ATHENEX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1.25MG/ML

0

ENALAPRILAT

ENALAPRILAT

FDA Submissions

	ORIG	1	AP	2000-08-22
LABELING; Labeling	SUPPL	7	AP	2010-05-27

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75634
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENALAPRILAT","activeIngredients":"ENALAPRILAT","strength":"1.25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENALAPRILAT","submission":"ENALAPRILAT","actionType":"1.25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)