ANDA 078591

HOSPIRA INC

FDA Drug Application

Application #078591

Application Sponsors

ANDA 078591

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-06-17
LABELING; Labeling	SUPPL	2	AP	2015-02-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-08-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-08-18	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	15
SUPPL	12	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78591
            [companyName] => HOSPIRA INC
            [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
        )

)