NDA 210282

HOSPIRA INC

FDA Drug Application

Application #210282

Documents

• Letter: 2021-06-23
• Label: 2021-06-24
• Review: 2022-05-12
• Letter: 2022-08-09
• Label: 2022-08-08

Application Sponsors

NDA 210282

HOSPIRA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS, SUBCUTANEOUS	350MG/VIAL	2	DAPTOMYCIN	DAPTOMYCIN
002	POWDER;INTRAVENOUS, SUBCUTANEOUS	500MG/VIAL	2	DAPTOMYCIN	DAPTOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	TBD
002	Prescription	TBD

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210282
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"},{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210282s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/210282s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/210282Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-21
        )

)