ANDA 206197

FRESENIUS KABI USA

FDA Drug Application

Application #206197

Documents

• Label: 2016-06-13
• Letter: 2016-06-10

Application Sponsors

ANDA 206197

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 150MG BASE/VIAL

0

FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 206197
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/09\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206197Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206197Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206197Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-06-09
        )

)