ANDA 207409

ALEMBIC PHARMS LTD

FDA Drug Application

Application #207409

Documents

• Letter: 2018-09-07

Application Sponsors

ANDA 207409

ALEMBIC PHARMS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005
• None (Tentative Approval): 006

Application Products

002	TABLET;ORAL	2MG	0	ILOPERIDONE	ILOPERIDONE
003	TABLET;ORAL	4MG	0	ILOPERIDONE	ILOPERIDONE
004	TABLET;ORAL	6MG	0	ILOPERIDONE	ILOPERIDONE
005	TABLET;ORAL	8MG	0	ILOPERIDONE	ILOPERIDONE
006	TABLET;ORAL	10MG	0	ILOPERIDONE	ILOPERIDONE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-07-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207409
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ILOPERIDONE","activeIngredients":"ILOPERIDONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207409Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-02
        )

)