ANDA 206803

RISING

FDA Drug Application

Application #206803

Application Sponsors

ANDA 206803

RISING

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

5MG

0

SELEGILINE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

RISING

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206803
            [companyName] => RISING
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELEGILINE HYDROCHLORIDE","activeIngredients":"SELEGILINE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-02
        )

)