ANDA 214222

GLAND PHARMA LTD

FDA Drug Application

Application #214222

Application Sponsors

ANDA 214222

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214222
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOTEPA","activeIngredients":"THIOTEPA","strength":"15MG\/VIAL","dosageForm":"POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-08
        )

)