NDA 212501

INGENUS PHARMS LLC

FDA Drug Application

Application #212501

Documents

• Letter: 2020-07-31
• Label: 2020-08-03
• Review: 2021-07-14
• Label: 2021-09-10
• Letter: 2021-09-13

Application Sponsors

NDA 212501

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	500MG/2.5ML	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE
002	INJECTABLE;INJECTION	1G/5ML	0	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE
003	SOLUTION;INTRAVENOUS	2G/10ML (200MG/ML)	2	CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2020-07-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212501
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/2.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1G\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/30\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212501s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/30\/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\\\/212501s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212501Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-07-30
        )

)