NDA 020122

HOSPIRA INC

FDA Drug Application

Application #020122

Documents

• Letter: 2019-10-29
• Label: 2019-10-29

Application Sponsors

NDA 020122

HOSPIRA INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/VIAL

1

NIPENT

PENTOSTATIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-10-11	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1994-07-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-12-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-10-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-05-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2009-09-22	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2013-06-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2015-12-29	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2019-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	12	Null	14
SUPPL	13	Null	14
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20122
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIPENT","activeIngredients":"PENTOSTATIN","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/28\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020122s015lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NIPENT","submission":"PENTOSTATIN","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-28
        )

)