ANDA 204015

MYLAN LABS LTD

FDA Drug Application

Application #204015

Documents

• Letter: 2019-10-04

Application Sponsors

ANDA 204015

MYLAN LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	EQ 115MG BASE/VIAL	0	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE
002	POWDER;INTRAVENOUS	EQ 150MG BASE/VIAL	0	FOSAPREPITANT DIMEGLUMINE	FOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-05

Submissions Property Types

ORIG

1

Null

19

TE Codes

002

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204015
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 115MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/05\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204015Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/17\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-17
        )

)