NDA 209445

SHIONOGI INC

FDA Drug Application

Application #209445

Documents

• Letter: 2019-11-15
• Label: 2019-11-15
• Review: 2019-12-19
• Label: 2020-09-28
• Letter: 2020-09-29
• Review: 2020-10-08
• Letter: 2021-11-15
• Label: 2021-11-15

Application Sponsors

NDA 209445

SHIONOGI INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 1GM BASE/VIAL

1

FETROJA

CEFIDEROCOL SULFATE TOSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-11-14	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2020-09-25	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	4	Null	7

CDER Filings

SHIONOGI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209445
            [companyName] => SHIONOGI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FETROJA","activeIngredients":"CEFIDEROCOL SULFATE TOSYLATE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209445s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209445s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209445s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209445Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209445Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/25\/2020","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209445s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209445Orig1s002ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/209445Orig1s002.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-25
        )

)