ANDA 090193

AM REGENT

FDA Drug Application

Application #090193

Documents

• Letter: 2008-11-28
• Label: 2009-01-16

Application Sponsors

ANDA 090193

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.2MG/ML

0

METHYLERGONOVINE MALEATE

METHYLERGONOVINE MALEATE

FDA Submissions

	ORIG	1	AP	2008-11-24
LABELING; Labeling	SUPPL	2	AP	2013-03-06	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90193
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLERGONOVINE MALEATE","activeIngredients":"METHYLERGONOVINE MALEATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/24\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/090193s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHYLERGONOVINE MALEATE","submission":"METHYLERGONOVINE MALEATE","actionType":"0.2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2008-11-24
        )

)