ANDA 214366

MSN LABS PVT LTD

FDA Drug Application

Application #214366

Application Sponsors

ANDA 214366

MSN LABS PVT LTD

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

2020-10-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214366
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"Erlotinib Hydrochloride","activeIngredients":"ERLOTINIB HYDROCHLORIDE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/08\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-08
        )

)