NDA 012111

ALCON

FDA Drug Application

Application #012111

Application Sponsors

NDA 012111

ALCON

Marketing Status

• Discontinued: 002
• Discontinued: 004

Application Products

002	SOLUTION/DROPS;OPHTHALMIC	0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	MYDRIACYL	TROPICAMIDE
004	SOLUTION/DROPS;OPHTHALMIC	1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	MYDRIACYL	TROPICAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

1960-02-23

STANDARD

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12111
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYDRIACYL","activeIngredients":"TROPICAMIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MYDRIACYL","activeIngredients":"TROPICAMIDE","strength":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYDRIACYL","submission":"TROPICAMIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MYDRIACYL","submission":"TROPICAMIDE","actionType":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)