ANDA 209594

MYLAN LABS LTD

FDA Drug Application

Application #209594

Documents

• Letter: 2018-04-05

Application Sponsors

ANDA 209594

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRATHECAL

1MG/ML

0

BACLOFEN

BACLOFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-10-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209594
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209594Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-06
        )

)