ANDA 204398

AKORN INC

FDA Drug Application

Application #204398

Documents

• Letter: 2017-09-29

Application Sponsors

ANDA 204398

AKORN INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;OPHTHALMIC	1%	0	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE
002	SOLUTION;OPHTHALMIC	2%	0	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE
003	SOLUTION;OPHTHALMIC	4%	0	PILOCARPINE HYDROCHLORIDE	PILOCARPINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-27

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AT
002	Prescription	AT
003	Prescription	AT

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204398
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"2%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PILOCARPINE HYDROCHLORIDE","activeIngredients":"PILOCARPINE HYDROCHLORIDE","strength":"4%","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204398Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-27
        )

)