ANDA 206858

MYLAN PHARMS INC

FDA Drug Application

Application #206858

Documents

• Letter: 2016-11-01

Application Sponsors

ANDA 206858

MYLAN PHARMS INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

10MG

0

DALFAMPRIDINE

DALFAMPRIDINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

MYLAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206858
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206858Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)