ANDA 203561

SCIEGEN PHARMS INC

FDA Drug Application

Application #203561

Application Sponsors

ANDA 203561

SCIEGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

12.5MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-14

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AB

CDER Filings

SCIEGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203561
            [companyName] => SCIEGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"12.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/14\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-14
        )

)