ANDA 212342

RICONPHARMA LLC

FDA Drug Application

Application #212342

Application Sponsors

ANDA 212342

RICONPHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

1MG/72HR

0

SCOPOLAMINE

SCOPOLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-24

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

RICONPHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212342
            [companyName] => RICONPHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SCOPOLAMINE","activeIngredients":"SCOPOLAMINE","strength":"1MG\/72HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-24
        )

)