ANDA 214263

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214263

Documents

• Letter: 2021-07-08

Application Sponsors

ANDA 214263

ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	40MG	0	OSIMERTINIB MESYLATE	OSIMERTINIB MESYLATE
002	TABLET;ORAL	80MG	0	OSIMERTINIB MESYLATE	OSIMERTINIB MESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-06-01

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214263
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSIMERTINIB MESYLATE","activeIngredients":"OSIMERTINIB MESYLATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-01
        )

)