ANDA 212991

AMNEAL

FDA Drug Application

Application #212991

Application Sponsors

ANDA 212991

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%;0.3%

0

TOBRAMYCIN AND DEXAMETHASONE

DEXAMETHASONE; TOBRAMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-07-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212991
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN AND DEXAMETHASONE","activeIngredients":"DEXAMETHASONE; TOBRAMYCIN","strength":"0.1%;0.3%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-15
        )

)