ANDA 213049

MSN

FDA Drug Application

Application #213049

Documents

• Letter: 2020-05-15

Application Sponsors

ANDA 213049

MSN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	15MG/VIAL	0	THIOTEPA	THIOTEPA
002	POWDER;INTRAVENOUS	100MG/VIAL	0	THIOTEPA	THIOTEPA

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

MSN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213049
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTEPA","activeIngredients":"THIOTEPA","strength":"15MG\/VIAL","dosageForm":"POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"THIOTEPA","activeIngredients":"THIOTEPA","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213049Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-04
        )

)