NDA 208746

HOSPIRA INC

FDA Drug Application

Application #208746

Documents

• Letter: 2021-01-12
• Letter: 2022-06-13
• Label: 2022-06-13
• Review: 2023-01-04

Application Sponsors

NDA 208746

HOSPIRA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	0	PEMETREXED	PEMETREXED
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED	PEMETREXED
003	POWDER;INTRAVENOUS	EQ 1G BASE/VIAL	0	PEMETREXED	PEMETREXED

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

TA

2021-01-08

STANDARD

Submissions Property Types

ORIG

1

Null

6

TE Codes

001	Prescription	TBD
002	Prescription	TBD
003	Prescription	TBD

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208746
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208746Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-08
        )

)