ANDA 209621

GLAND PHARMA LTD

FDA Drug Application

Application #209621

Application Sponsors

ANDA 209621

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 10MG BASE/ML	0	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE
002	INJECTABLE;INJECTION	EQ 40MG BASE/ML	0	TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-02-11

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] => 209621
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TOBRAMYCIN SULFATE","activeIngredients":"TOBRAMYCIN SULFATE","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-11
        )

)