ANDA 202857

HOSPIRA INC

FDA Drug Application

Application #202857

Documents

• Letter: 2014-09-16

Application Sponsors

ANDA 202857

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

500MG/VIAL

0

DAPTOMYCIN

DAPTOMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-09-12
LABELING; Labeling	SUPPL	2	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-07-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-10-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	16	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202857
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202857Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/03\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/31\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2016","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2016","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-03
        )

)