NDA 208419

ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P

FDA Drug Application

Application #208419

Documents

• Letter: 2020-08-24
• Review: 2021-07-12
• Label: 2022-11-23
• Label: 2022-11-23
• Label: 2022-11-23
• Letter: 2022-11-25
• Letter: 2022-11-25
• Letter: 2022-11-25

Application Sponsors

NDA 208419

ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	100MG/4ML	0	PEMETREXED	PEMETREXED
002	INJECTABLE;INJECTION	500MG/20ML	0	PEMETREXED	PEMETREXED
003	INJECTABLE;INJECTION	1G/40ML	0	PEMETREXED	PEMETREXED

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2020-08-21	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2022-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2022-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2022-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	4	Null	6

CDER Filings

ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208419
            [companyName] => ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG\/20ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"1G\/40ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208419Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-21
        )

)