ANDA 211083

ACCORD HLTHCARE INC

FDA Drug Application

Application #211083

Documents

• Letter: 2019-06-17

Application Sponsors

ANDA 211083

ACCORD HLTHCARE INC

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 25MG BASE	0	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE
002	TABLET;ORAL	EQ 100MG BASE	0	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE
003	TABLET;ORAL	EQ 150MG BASE	0	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-05-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211083
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ERLOTINIB HYDROCHLORIDE","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211083Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)