ANDA 208324

ALEMBIC PHARMS LTD

FDA Drug Application

Application #208324

Documents

• Letter: 2018-12-20

Application Sponsors

ANDA 208324

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

10MG

0

VARDENAFIL HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208324
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VARDENAFIL HYDROCHLORIDE","activeIngredients":"VARDENAFIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208324Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-16
        )

)