ANDA 205309

AKORN

FDA Drug Application

Application #205309

Documents

• Letter: 2016-10-05

Application Sponsors

ANDA 205309

AKORN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AT
002	Prescription	AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205309
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL","activeIngredients":"TIMOLOL","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL","activeIngredients":"TIMOLOL","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205309Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-30
        )

)