ANDA 216736

RUBICON

FDA Drug Application

Application #216736

Application Sponsors

ANDA 216736

RUBICON

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

20MG

0

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-14

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216736
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/14\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-14
        )

)