NDA 209472

EAGLE PHARMS

FDA Drug Application

Application #209472

Documents

• Label: 2020-02-10
• Letter: 2020-02-10
• Letter: 2020-06-18
• Review: 2020-09-16
• Label: 2022-02-16
• Letter: 2022-12-15
• Label: 2022-12-19

Application Sponsors

NDA 209472

EAGLE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

500MG/20ML (25MG/ML)

1

PEMFEXY

PEMETREXED

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2020-02-08	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	6

CDER Filings

EAGLE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209472
            [companyName] => EAGLE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMFEXY","activeIngredients":"PEMETREXED","strength":"500MG\/20ML (25MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/08\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209472s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/08\/2020","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\\\/2020\\\/209472s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209472Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/209472Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209472Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-21
        )

)