ANDA 216533

INGENUS PHARMS LLC

FDA Drug Application

Application #216533

Application Sponsors

ANDA 216533

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	0	TIMOLOL MALEATE	TIMOLOL MALEATE
002	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	0	TIMOLOL MALEATE	TIMOLOL MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AT3
002	Prescription	AT3

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216533
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-13
        )

)