ANDA 216648

GLAND PHARMA LTD

FDA Drug Application

Application #216648

Application Sponsors

ANDA 216648

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/VIAL

0

MITOMYCIN

MITOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216648
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MITOMYCIN","activeIngredients":"MITOMYCIN","strength":"40MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MITOMYCIN","submission":"MITOMYCIN","actionType":"40MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)