ANDA 078261

AKORN

FDA Drug Application

Application #078261

Application Sponsors

ANDA 078261

AKORN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-04-14
LABELING; Labeling	SUPPL	2	AP	2015-02-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-05-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2020-05-20	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	4	Null	15
SUPPL	7	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78261
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROMORPHONE HYDROCHLORIDE","submission":"HYDROMORPHONE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)