ANDA 202869

HOSPIRA INC

FDA Drug Application

Application #202869

Documents

• Review: 2012-10-09

Application Sponsors

ANDA 202869

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

500MG/5ML (100MG/ML)

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-04-06
LABELING; Labeling	SUPPL	2	AP	2021-07-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-07-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-07-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-07-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-07-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-07-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	8	Null	7
SUPPL	10	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202869
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202869Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-04-06
        )

)