ANDA 209113

NESHER PHARMS

FDA Drug Application

Application #209113

Documents

• Letter: 2017-09-19
• Label: 2017-09-21

Application Sponsors

ANDA 209113

NESHER PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

EQ 6MG BASE/ML

0

OSELTAMIVIR PHOSPHATE

OSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-12-03	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-12-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-12-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209113
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/14\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209113Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209113Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209113Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-03
        )

)