ANDA 040498

MYLAN INSTITUTIONAL

FDA Drug Application

Application #040498

Application Sponsors

ANDA 040498

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-07-12
LABELING; Labeling	SUPPL	11	AP	2015-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	11	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40498
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)