ANDA 208396

APOTEX

FDA Drug Application

Application #208396

Application Sponsors

ANDA 208396

APOTEX

Marketing Status

• Prescription: 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

AP

2019-11-05

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208396
            [companyName] => APOTEX
            [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":"11\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-05
        )

)