ANDA 210680

MAYNE PHARMA INC

FDA Drug Application

Application #210680

Application Sponsors

ANDA 210680

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

0.1MG

0

CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-04-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB1

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210680
            [companyName] => MAYNE PHARMA INC
            [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":"04\/30\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-29
        )

)