ANDA 211824

ALEMBIC PHARMS LTD

FDA Drug Application

Application #211824

Documents

• Letter: 2019-12-10
• Letter: 2019-12-10

Application Sponsors

ANDA 211824

ALEMBIC PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	90MG	0	DEFERASIROX	DEFERASIROX
002	TABLET;ORAL	360MG	0	DEFERASIROX	DEFERASIROX
003	TABLET;ORAL	180MB	0	DEFERASIROX	DEFERASIROX

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-11-20	STANDARD
UNKNOWN;	ORIG	2	TA	2019-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
ORIG	2	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211824
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"90MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"360MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/15\/2020","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211824Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211824Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-15
        )

)