ANDA 215540

BELCHER

FDA Drug Application

Application #215540

Application Sponsors

ANDA 215540

BELCHER

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

0

CHLORZOXAZONE

CHLORZOXAZONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

BELCHER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215540
            [companyName] => BELCHER
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORZOXAZONE","activeIngredients":"CHLORZOXAZONE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-24
        )

)