ANDA 040136

AM REGENT

FDA Drug Application

Application #040136

Documents

• Label: 2014-02-28
• Letter: 2014-02-28
• Review: 2003-07-30

Application Sponsors

ANDA 040136

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1997-06-30
LABELING; Labeling	SUPPL	5	AP	2013-04-26	STANDARD

Submissions Property Types

SUPPL

5

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40136
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/26\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/040136s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"20MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2013-04-26
        )

)