ANDA 204372

NOVAST LABS

FDA Drug Application

Application #204372

Documents

• Letter: 2015-07-24

Application Sponsors

ANDA 204372

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

324MG

0

QUININE SULFATE

QUININE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-07-22

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204372
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUININE SULFATE","activeIngredients":"QUININE SULFATE","strength":"324MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204372Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/11\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-11
        )

)