ANDA 208823

ALVOGEN PINE BROOK

FDA Drug Application

Application #208823

Application Sponsors

ANDA 208823

ALVOGEN PINE BROOK

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	2017-10-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-12-16	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-12-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-12-16	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN PINE BROOK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208823
            [companyName] => ALVOGEN PINE BROOK
            [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] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-31
        )

)