ANDA 211189

GLAND PHARMA LTD

FDA Drug Application

Application #211189

Application Sponsors

ANDA 211189

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1.2GM BASE/VIAL

0

TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-18

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211189
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 1.2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-18
        )

)