ANDA 209675

NOVAST LABS

FDA Drug Application

Application #209675

Application Sponsors

ANDA 209675

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

0.1MG

0

CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-03-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB1

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209675
            [companyName] => NOVAST LABS
            [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":"03\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-14
        )

)