ANDA 214645

GLAND PHARMA LTD

FDA Drug Application

Application #214645

Application Sponsors

ANDA 214645

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

EQ 0.25% BASE

0

TIMOLOL MALEATE

TIMOLOL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214645
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION, GEL FORMING\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"EQ 0.25% BASE","submissionClassification":"SOLUTION, GEL FORMING\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)