NDA 214657

SANDOZ INC

FDA Drug Application

Application #214657

Documents

• Letter: 2021-05-10
• Label: 2022-05-27
• Review: 2022-12-05

Application Sponsors

NDA 214657

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	SOLUTION;INTRAVENOUS	100MG/4ML (25 mg/mL)	0	Pemetrexed	Pemetrexed
002	SOLUTION; INJECTION	500MG/20ML (25MG/ML)	0	Pemetrexed	Pemetrexed
003	SOLUTION;INTRAVENOUS	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	1	PEMETREXED	PEMETREXED DISODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2021-05-06

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214657
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"Pemetrexed","activeIngredients":"Pemetrexed","strength":"100MG\/4ML (25 mg\/mL)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"Pemetrexed","activeIngredients":"Pemetrexed","strength":"500MG\/20ML (25MG\/ML)","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"Pemetrexed","activeIngredients":"Pemetrexed","strength":"1000MG\/40ML (25MG\/ML)","dosageForm":"SOLUTION; INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214657Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-06
        )

)