ANDA 212411

SINOTHERAPEUTICS INC

FDA Drug Application

Application #212411

Documents

• Letter: 2019-10-03

Application Sponsors

ANDA 212411

SINOTHERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

100MG

0

POSACONAZOLE

POSACONAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-07-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-07-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-07-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SINOTHERAPEUTICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212411
            [companyName] => SINOTHERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"100MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212411Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-21
        )

)