ANDA 203640

APOTEX INC

FDA Drug Application

Application #203640

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 203640

APOTEX INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	EQ 50MG BASE	0	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE
002	CAPSULE;ORAL	EQ 150MG BASE	0	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE
003	CAPSULE;ORAL	EQ 200MG BASE	0	NILOTINIB HYDROCHLORIDE	NILOTINIB HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-10

STANDARD

Submissions Property Types

ORIG

1

Null

19

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203640
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NILOTINIB HYDROCHLORIDE","activeIngredients":"NILOTINIB HYDROCHLORIDE","strength":"EQ 200MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-10
        )

)