ANDA 203753

MYLAN TECHNOLOGIES

FDA Drug Application

Application #203753

Documents

• Review: 2020-03-24

Application Sponsors

ANDA 203753

MYLAN TECHNOLOGIES

Marketing Status

• Prescription: 001

Application Products

001

FILM, EXTENDED RELEASE;TRANSDERMAL

1MG/72HR

0

SCOPOLAMINE

SCOPOLAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-19

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

MYLAN TECHNOLOGIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203753
            [companyName] => MYLAN TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SCOPOLAMINE","activeIngredients":"SCOPOLAMINE","strength":"1MG\/72HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/203753Orig1s000ChemR.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-19
        )

)