ANDA 211642

NOVITIUM PHARMA

FDA Drug Application

Application #211642

Documents

• Letter: 2019-05-22

Application Sponsors

ANDA 211642

NOVITIUM PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE;ORAL	1MG	0	THIOTHIXENE	THIOTHIXENE
002	CAPSULE;ORAL	2MG	0	THIOTHIXENE	THIOTHIXENE
003	CAPSULE;ORAL	5MG	0	THIOTHIXENE	THIOTHIXENE
004	CAPSULE;ORAL	10MG	0	THIOTHIXENE	THIOTHIXENE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211642
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"THIOTHIXENE","activeIngredients":"THIOTHIXENE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211642Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-05
        )

)