ANDA 208347

LUPIN ATLANTIS

FDA Drug Application

Application #208347

Application Sponsors

ANDA 208347

LUPIN ATLANTIS

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	2018-02-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-12-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-12-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-07-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208347
            [companyName] => LUPIN ATLANTIS
            [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":"02\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-20
        )

)