ANDA 209323

ACTAVIS LLC

FDA Drug Application

Application #209323

Documents

• Letter: 2020-05-14

Application Sponsors

ANDA 209323

ACTAVIS LLC

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 50MG BASE/VIAL

0

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-03-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209323
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN HYDROCHLORIDE","activeIngredients":"MELPHALAN HYDROCHLORIDE","strength":"EQ 50MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209323Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-06
        )

)