ANDA 206553

APPCO

FDA Drug Application

Application #206553

Application Sponsors

ANDA 206553

APPCO

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

4MG

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

APPCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206553
            [companyName] => APPCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-29
        )

)