ANDA 203434

NOVAST LABS

FDA Drug Application

Application #203434

Documents

• Letter: 2016-10-05

Application Sponsors

ANDA 203434

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

500MG

0

ACETAZOLAMIDE

ACETAZOLAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-30

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203434
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"500MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203434Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-30
        )

)