ANDA 209346

GLAND PHARMA LTD

FDA Drug Application

Application #209346

Application Sponsors

ANDA 209346

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 40MG BASE/ML

0

TOBRAMYCIN SULFATE (PHARMACY BULK)

TOBRAMYCIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209346
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN SULFATE (PHARMACY BULK)","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-09
        )

)