ANDA 209757

XIAMEN LP PHARM CO

FDA Drug Application

Application #209757

Application Sponsors

ANDA 209757

XIAMEN LP PHARM CO

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

0.1MG

0

CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB1

CDER Filings

XIAMEN LP PHARM CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209757
            [companyName] => XIAMEN LP PHARM CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLONIDINE HYDROCHLORIDE","activeIngredients":"CLONIDINE HYDROCHLORIDE","strength":"0.1MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-20
        )

)